INCELL Corporation LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes [21 CFR211.113(b)]. For example, the aseptic processes used to manufacture your product have not been validated (e.g., by performing media fill simulations) since your firm’s manufacturing operations for the subject product began in February 2020.

Passage 2

Failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity [21 CFR211.160(b)]. For example, you have not established scientifically sound and appropriate specifications to assure that your product conforms to appropriate standards of identity. Your specification for finished product testing does not include a requirement to perform identity testing.

Passage 3

Failure to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)]. Specifically, your certificate of analysis for your product states that the expiry period is (b)(4), while your instructions for use (IFU) labels your product as having a “(b)(4).” You therefore assigned (b)(4) expiration dates to your product without supporting data regarding the stability characteristics of the product.

Passage 4

Your product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your labeling is false or misleading. Specifically, the IFU for your product indicates that “(b)(4).” This description implies that your product is provided as (b)(4) when it is actually a (b)(4). Further, as noted above, your certificate of analysis for your product states that the expiry period is (b)(4), while your IFU states that your product has a “(b)(4).” Neither of these statements about the stability of your product are supported with stability data.

Passage 5

documents provided during the inspection lack evidence that adequate environmental monitoring takes place in the (b)(4) ISO (b)(4) manufacturing environment where (b)(4) is exposed to the environment during processing. Specifically, results associated with batch records only include passive microorganism monitoring (i.e., (b)(4)) and non-viable particulate monitoring. There is no mention of viable microorganism monitoring such as (b)(4) sampling and personnel monitoring in association with each batch.