Findings
1Quality unit oversight
Your firm failed to withhold each lot of components from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. Your firm further failed to take representative samples of each shipment of each lot of components for testing or examination [21 CFR 211.84(a) and 21 CFR 211.84(b)]. Specifically, your firm failed to withhold each lot of PCM (b)(4) from use in AXIOFILL™ processing until the lot had been tested to…
2Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity [21 CFR 211.160(b)]. Specifically, your firm has not established laboratory controls that include appropriate final specifications for testing and release of AXIOFILL™ to assure that each batch conforms to appropriate standards of identity and purity during routine production.
3Laboratory and QC controls
Your firm has failed to conduct at least one test to verify the identity of each component of a drug product using specific identity tests, if they exist [21 CFR 211.84(d)(1)]. Specifically, your firm does not perform at least one test to verify the identity of each lot of “Placental Collagen Matrix (PCM) (b)(4) ” using the specific identity test that exists. Although your firm indicated that the test used to determine the concentration of PCM (b)(4) is considered an identity test, only concentration results and not identity are reported to you by the contract laboratory. PCM (b)(4) is used to manufacture AXIOFILL™.
4Other quality system
Drug product samples are not representative of the entire batch [21 CFR 211.160(b)(3)]. For example, samples of AXIOFILL™ tested for residual moisture as a measure of purity per your finished product specification are not representative of the entire batch. According to CSOP220.116, Product Visual Inspection (revision 54, effective 12/09/22), only (b)(4) of each lot of your Placental Collagen Matrix product is collected for residual moisture testing. There are no considerations for batch size. This is not representative because, when products are lyophilized,moisture content can vary across the lot.
5Aseptic processing and sterility assurance
In-process control procedures are deficient in that your control procedures do not include bioburden testing [21 CFR 211.110(a)(6)]. According to your Process Performance Qualification Report for Placental Collagen Matrix (PCM) (effective 2/20/23), your firm removed (b)(4) bioburden testing from routine commercial production of AXIOFILL™ after completing “validation production.” Your product is (b)(4) sterilized. In-process bioburden testing is critical for assuring that bioburden levels do not exceed the validated sterility assurance level (SAL).
6Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug product has the identity, strength, purity, and quality it purports or is represented to possess [21 CFR 211.100(a)]. Specifically, your firm has manufactured and distributed AXIOFILL™ without establishing adequate written procedures to assure that your process is capable of consistently producing product that meets appropriate attributes relating to…
About this record
Extracted automatically from the document US FDA published on 2024-01-09. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
