FDA 483 - CP Pharmaceuticals Limited - October 13, 2015

On October 13, 2015, an FDA Form 483 was issued to CP Pharmaceuticals in Wrexham, U.K., following an inspection. The inspection revealed significant deficiencies in the facility's quality control and manufacturing processes, particularly concerning sterile drug products.

A key observation was the failure to adequately investigate out-of-specification (OOS) results for sterility tests. Specifically, the firm did not conduct a thorough investigation into the root cause of a confirmed positive sterility test result for a batch of product, instead attributing it to laboratory error without sufficient evidence. This indicates a lack of robust quality control procedures and a failure to adhere to 21 CFR 211.192, which requires thorough investigations of any unexplained discrepancies or failures of a batch or its components to meet specifications.

Furthermore, the firm's environmental monitoring program was found to be deficient. There was no established alert or action limit for viable particles in the Grade C cleanroom, and the firm failed to investigate excursions above the established limits for non-viable particles in the as-built Grade A/B cleanroom. This suggests inadequate control over the manufacturing environment, posing a risk to product sterility and violating 21 CFR 211.42(c)(10)(iv), which mandates appropriate environmental controls.

The inspection also noted that the firm's quality unit responsibilities were not fully met, as evidenced by the inadequate investigations and environmental monitoring.