1Deviation, CAPA, and investigation
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). You lack adequate investigations into failing microbiological results for both finished drug products and components. A. In October 2020, your third-party laboratory identified Burkholderia cepacia complex (BCC), specifically Burkholderia lata in Paroex…
2Laboratory and QC controls
Your firm failed 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, strength, quality, and purity (21 CFR 211.160(b)). Your non-sterile aqueous-based drug product specifications did not include Burkholderia cepacia…
3Documentation and records
Failure to conduct, control and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70. Specifically, the Master Filling/Packaging batch record for Hydral Dry Mouth Spray, Lot C164FT section 2.2.5 requires the use of the (b)(4) . The (b)(4) by the line mechanic (b)(4) for the Hydral Dry Mouth Spray, Lot C164FT. Your firm’s OOS-907 states that the filter was likely not effective throughout the entire fill of the lot…
4Cleaning validation
Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63) Your manufacturing equipment is not designed and maintained appropriately. (b)(4) Upon our request, you (b)(4) installed on (b)(4) . Our investigators observed residue inside the (b)(4) after the equipment had…
5Cleaning validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). You did not adequately validate the processes used to clean your non-dedicated, product-contact equipment. A. You observed residue on (b)(4) during the 0.12% chlorhexidine gluconate oral rinse cleaning validation…
