Jagsonpal Pharmaceuticals Limited

The U.S. Food and Drug Administration (FDA) inspected your registered facility, Jagsonpal Pharmaceuticals Limited, FEI 3004153045, located at B-1124, RIICO Industrial Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, on March 20, March 27, and April 3, 2024.

This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for APIs.

Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

(b)(4) is not duly listed with FDA as required by section 510(j) of the FD&C Act. Failure to provide correct listing information required by section 510(j) is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p), and will render a drug misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

We reviewed your April 22, 2024 response to our Form FDA 483 in detail, and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigator observed specific deviations including, but not limited to, the following.

Your firm utilized a contract manufacturing organization (CMO), (b)(4), to perform manufacturing, processing, and packaging activities on your behalf. You received drugs from this CMO and declared your firm as the manufacturer on import records. Additionally, you registered your firm with the FDA (b)(4). (b)(4) is not registered as a drug manufacturer with the FDA.

A written agreement with your CMO, provided during the inspection, describes the responsibilities of your firm in the manufacturing of (b)(4). For example, Jagsonpal personnel are responsible for supervising the manufacturing and analysis of (b)(4) and assuring your CMO adheres to CGMP.

However, you did not adequately ensure that process validation was completed by your CMO, that master production instructions were complete, and that compendial methods used to analyze your product were appropriately verified as suitable for their intended use.

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. 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. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov>media>download.

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

In response to this letter, provide

A comprehensive assessment and remediation plan for your QU oversight, including qualification of your contract manufacturers, to evaluate adherence to appropriate practices.

Confirmation that your CMO, (b)(4), is registered with the FDA.

On March 15, 2024, the FDA arrived at the registered address, B-1124, RIICO Ind. Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, 301019, India, to conduct an inspection and was refused entry by individuals present at this address.

On March 20, 2024, the FDA was permitted to enter the facility at the registered address to conduct an inspection; however, access to requested documents was limited during the inspection. For example, complete analytical data, equipment logbooks, and change control documents were not provided upon request because, according to your representatives, the facility was in (b)(4) status. Representatives from Jagsonpal and your CMO were present during these requests.

When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/circumstances-constitute-delaying-denying-limiting-or-refusing-drug-or-device-inspection.

Under section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 of FDA regulations, firms that manufacture, prepare, propagate, compound, or process drugs in the United States or that are offered for import into the United States must be registered with the FDA. Every person who is required to register must, at the time of initial registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution under section 510(j)(1) of the FD&C Act, 21 U.S.C. 360(j)(1). Private label distributors who do not perform any manufacturing activities but distribute the products under their name and label are not required to register, but their products must be listed under their own labeler code. In addition, in accordance with section 510(j)(2) of the FD&C Act, 21 U.S.C. section 360(j)(2), and 21 CFR 207.57(b), registrants are required to submit updated drug listing information to the FDA twice each year, in June and December, notifying FDA if this information has changed.

(b)(4) was manufactured at an unregistered facility, (b)(4), and was not listed by them as required under 21 CFR 207.41(a), thus causing (b)(4) to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o).

For each drug bearing an NDC, the name of the establishment where the drug is manufactured in accordance with 21 CFR 207.49(a)(12) must be provided. (b)(4) does not include correct manufacturer information in the listing and includes Jagsonpal Pharmaceuticals Ltd. as the manufacturer instead of (b)(4). You should include (b)(4) in your product listing as the manufacturer of (b)(4). Therefore, (b)(4) is not compliant as required by section 510(j) of the FD&C Act while in commercial distribution, rendering this drug to be misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). In addition, failure to provide current listing information in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).

It remains your responsibility to ensure that (b)(4) and all products manufactured at any of your establishments or distributed under your name and label comply with all registration and listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, and 21 CFR Part 207 of FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions | FDA.

FDA considers the expectations outlined in ICH Q7 when determining whether APIs are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.

Based upon the nature of the deviations we identified, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

The deviations cited in this letter are not intended to be an all-inclusive list. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.

FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on January 17, 2025.

Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.

Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured by Jagsonpal Pharmaceuticals, or listing the address B-1124, RIICO Ind. Area, Phase-III, Bhiwadi Dist., Alwar, Rajasthan, 301019, India, as the manufacturer, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B) and are misbranded under section 502 of the FD&C Act, respectively.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004153045 and ATTN: Maria Pavco.