WARNING LETTER Deb USA Inc. MARCS-CMS 570944 — JUNE 11, 2019
2. 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)).
You did not have a procedure governing (b)(4) of High Performance Liquid Chromatography (HPLC) data. Additionally, your procedure did not require the same number of replicate HPLC injections ((b)(4)) to average and obtain a final result.
Our investigators identified several examples of your firm using (b)(4) and reporting passing results without adequate procedural controls or justification. For instance, Deb Pure Bac Foam Wash, lot 049559, initially failed during (b)(4) and upon (b)(4) yielded a passing result that was reported...
3. Your firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a)).
Laboratory personnel failed to follow written procedures for testing components and drug products. For example:
A. Your personnel failed to follow your procedure for enumeration of viable microorganisms. Your procedure requires (b)(4) and (b)(4) in (b)(4) on both (b)(4) and (b)(4). Your firm’s practice is to prepare (b)(4) on a (b)(4) plate and a (b)(4) plate for incubation.
B. Your procedure for enumeration of viable microorganisms required (b)(4) to be tested per (b)(4). However, your firm tested (b)(4) samples on the same (b)(4). In your response, you acknowledged testing (b)(4) samples on the same (b)(4).
C. Many microbiological testing activities were not contemporaneously documented. Significantly, our investigators found microbiological test plates in a laboratory trash can with no written record of their receipt, preparation, incubation, or reading. The test sheets for the undocumented plates were not completed and the employee stated he would record the results later from memory...
C. Many microbiological testing activities were not contemporaneously documented. Significantly, our investigators found microbiological test plates in a laboratory trash can with no written record of their receipt, preparation, incubation, or reading. The test sheets for the undocumented plates were not completed and the employee stated he would record the results later from memory...
4. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Our inspection found instances in which your firm overwrote electronic testing data, discarded original testing records, and failed to report OOS laboratory test results. For example:
A. Your HPLC software configuration allows users to overwrite data resulting in original data being irretrievable. A torn-up HPLC chromatogram was discovered in a dumpster outside your facility on October 23, 2018. The chromatogram was for a stability testing assay result for Refresh PureBac Foam, lot 044262. The electronic file and method were manipulated yielding different results. The data manipulation was not captured in the audit trail and the passing result from a single injection was reported on the “OTC Stability Testing Results” form.
A. Your HPLC software configuration allows users to overwrite data resulting in original data being irretrievable. A torn-up HPLC chromatogram was discovered in a dumpster outside your facility on October 23, 2018. The chromatogram was for a stability testing assay result for Refresh PureBac Foam, lot 044262. The electronic file and method were manipulated yielding different results. The data manipulation was not captured in the audit trail and the passing result from a single injection was reported on the “OTC Stability Testing Results” form.
B. The OOS result from HPLC assay testing of Brady Clear, lot 8072, was not reported. Two injections of the sample were performed and yielded results of 0.516808% and 0.495222%. Your procedure requires the results to be averaged (specification of (b)(4)). However, rather than reporting the average assay result, which failed, you reported the initial single injection result that was (b)(4) to meet the specification (b)(4).
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