Tailstorm Health Inc. dba Medivant Health

You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on October 23, 2019, and most recently on December 18, 2024. From September 24, 2024, to October 10, 2024, an FDA investigator inspected your facility, Tailstorm Health Inc. dba Medivant Health located at 24416 N. 19th Avenue Suite 200, Phoenix, AZ 85085. During the inspection, the investigator collected evidence that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 and an amended Form FDA 483 to your facility on October 10, 2024. FDA acknowledges receipt of your facility’s responses, dated October 31, 2024, December 9, 2024, and January 23, 2025. FDA also acknowledges that on November 6, 2024, your firm initiated a voluntary recall of lots D24005, D24006, D24007, D24008, D24009, and D24012 of Bevacizumab (Avastin) 1.25mg/0.05mL, 0.5 mL Single-Dose Syringe, intended or expected to be sterile, within expiry, due to lack of sterility assurance. Based on this inspection, it appears you produced drugs that violate the FDCA.

Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2

An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.

In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. § 353b(a)(10)]).

Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).

During the inspection, the FDA investigator noted that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator collected evidence that:

1. Your facility’s drug products, such as Semaglutide Injection 1mg/0.2ml and Tirzepatide Injection 2.5mg/0.5ml, did not include the following on the label: “Office Use Only.”

2. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations). Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not describe an adverse event as “unexpected” when one is not listed in the current labeling for the drug product (21 CFR 310.305(b) and do not provide that adverse events should be reported utilizing FDA’s Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG) (21 CFR 310.305(e)).3

Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.

Specific violations are described below.

The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:

1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

2. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).

Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a), the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

You do not have any FDA-approved applications on file for drug products that you compound.4 Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.

You compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.5 The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, it is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

We have reviewed your facility’s responses to the Form FDA 483. We also acknowledge your recall of lots D24005, D24006, D24007, D24008, D24009, and D24012 of repackaged Bevacizumab (Avastin) 1.25mg/0.05mL, 0.5 mL Single-Dose Syringe, intended or expected to be sterile, within expiry, due to lack of sterility assurance.

Regarding your responses related to the insanitary conditions and CGMP violations, some of your proposed corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:

1. Regarding particulate matter testing of your finished drug products:

a. We have reviewed your document titled, “Retrospective Review Investigation of Reported OOS incidents (1B).” Within that document, you state, “Tailstorm has researched the product Avastin, which contains Bevacizumab, a protein that may interfere with liquid-borne particle count testing. The nature of the product can lead to inconsistent results when tested microscopically using Method (b)(4).” You also stated that, “The test method and procedure were found to involve many physical maneuvers” and that, “the preliminary sample preparation steps are not protected under a bio-safety cabinet/LAF (laminar air flow).” Despite these concerns, your firm relied on passing results via method (b)(4) to release lots D24006, D24007, and D24009.

b. Your response did not address the approval process for changes occurring at your contract testing facility. FDA is aware that many drug manufacturers use independent contractors such as testing laboratories. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facility. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contract-manufacturing-arrangements-drugs-quality-agreements-guidance-industry.

c. For Bevacizumab lot D24008, your investigation identified elastomer/rubber particles and noted, “source is syringe stopper or syringe cap rubber seal.” However, you did not provide the actions you took to correct and prevent the recurrence of these particles. Your action plans should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, and quality assurance oversight.

Some of your corrective actions appear deficient:

1. Regarding your updated smoke studies provided in your response:

a. The dynamic smoke study in your video titled “Removal of (b)(4) layer from the tub” under file name “Act 21” does not show smoke in the area in which the open tub of what appears to be product syringes is moved during time 00:51 to 00:58. This same area shows air turbulence during your static smoke study video “(b)(4) Removal” under file name “Act (b)(4)” during time (b)(4).

b. The smoke study in your video titled “Replacement of Needle (Open door)” under file name “Act 44” does not appear to encompass all areas within the ISO 5 (b)(4) including but not limited to the interventions performed by the operator during needle replacement.

2. Regarding your personnel monitoring program, we have reviewed your provided evaluation and acknowledge your statement that, “the practice of breaking first air with the head and chest during open (b)(4) doors interventions has been remediated.” We also acknowledge that you have updated your SOP to “add personnel monitoring sample sites of the right shoulder and left shoulder for the machine assembly process.” However, in our review of your updated smoke study titled “Act 15” it appears that your operator’s head and goggles enter the ISO 5 space within the (b)(4).

In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]

In addition, regarding issues related to the conditions of section 503B of the FDCA, some of your corrective actions appear adequate: You state that you have “revised the affected labels to include the necessary statements and enhance the label review and approval process to ensure compliance with all regulatory standards in the future.”

You did not address certain issues related to the conditions of section 503B of the FDCA. More specifically, your SOP for adverse event reporting does not adequately address adverse event reporting. For example, your procedures do not adequately define what constitutes an “unexpected” adverse event and your procedures do not provide that adverse events should be reported utilizing the Safety Reporting Portal (SRP) or Electronic Submission Gateway (ESG).

Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

All correspondence should refer to the Warning Letter Number above (# 703497) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.