PolyPeptide Laboratories, Inc. – FDA EIR, Aug 30, 2019

An unannounced cGMP surveillance inspection of PolyPeptide Laboratories, Inc. in Torrance, CA was conducted from August 26-30, 2019. The company manufactures synthetic peptides used in human and animal drugs, operating under the regulatory framework of the FD&C Act and cGMP guidelines for Active Pharmaceutical Ingredients and animal drug manufacturing. The inspection resulted in one FDA 483 observation for failure to follow established written procedures. Specifically, the firm inadequately investigated a customer complaint regarding plastic contamination in a drug substance. Although a root cause was identified, the investigation did not extend to other batches of the same product or other products utilizing the same manufacturing process, despite the process's widespread use. Additionally, the firm failed to identify negative trends or implement corrective actions for multiple deviations related to missed system sampling, which were repeatedly attributed to "human error." Management discussions also highlighted issues such as insufficient tracking for a major QC laboratory relocation, discrepancies in equipment calibration labeling, and concerns over laboratory sample control, where a sample was not listed in logbooks. The company's President acknowledged the observations and committed to submitting a written response to the FDA within 15 business days, including an updated deviation procedure.