Cosmetic Science Laboratories LLC in Torrance, CA, and Formology Lab Inc. in Chatsworth, CA, have been issued Warning Letters by the United States Food & Drug Administration (FDA) for substantial violations of Current Good Manufacturing Practice (CGMP) regulations for all finished pharmaceuticals. The FDA cited insufficient detail or evidence of corrective actions in the response from Cosmetic Science Laboratories during an inspection conducted between September 6-20, 2022.
The FDA noted various violations, such as failing to conduct identity tests for drug components and relying on certificates of analysis (COAs) from suppliers without establishing their reliability. The company also failed to establish adequate written procedures for production and process control, as well as prepare batch production and control records with complete information. The FDA cited a lack of adequate batch records, cleaning validation, equipment qualification, and proper water system design, control, and monitoring.
Formology Lab Inc.’s Warning Letter, dated March 1, 2023, cited significant violations of CGMP regulations for finished pharmaceuticals during an inspection conducted from August 30 to September 9, 2022. The FDA found the company’s response to be inadequate and lacking in detail regarding the revision of procedures for receiving and testing components, timelines for implementation, and specific testing to be performed.
The company failed to establish written procedures for production and process control, ensure drug products’ identity, strength, quality, and purity, and provide documentation showing that the manufacturing processes for its over-the-counter sunscreen products had been validated. Moreover, Formology could not provide data demonstrating that the water used to manufacture drug products met the United States Pharmacopeia (USP) monograph and was fit for pharmaceutical use.
Formology’s Master Validation Plan was found to be inadequate, as it lacked sufficient information on the planned validation activities and timelines for completion. The company also failed to establish an adequate quality unit with written procedures and responsibilities for critical oversight activities, such as investigations, management of changes, customer complaints, training, corrective actions and preventive actions (CAPAs), deviations, and annual product reviews.
The FDA noted that Formology did not have appropriate stability data to demonstrate that the drug products’ chemical and microbiological properties met established specifications and remained acceptable throughout their assigned shelf-life. The company also failed to conduct an adequate investigation for out-of-specification (OOS) viscosity results.
The FDA emphasized in both letters that contract facilities are responsible for the quality of drugs they produce, regardless of agreements with product owners, and are required to make sure that medications or drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity.
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