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Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.
FDA sent a warning letter on Dec. 15, 2016 to Pharmco Laboratories, Inc. following an inspection of the company’s facility in Titusville, Florida from Nov. 9–30, 2015. FDA found significant violations of cGMP for finished drugs and APIs as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products. FDA noted that the facility had similar cGMP deficiencies documented in previous inspections.
During the 2015 inspection, FDA found that the firm failed to establish adequate written procedures for production and process control of its finished drug products. FDA wrote that the company had not validated its topical OTC drug products’ manufacturing processes, and it had not validated the reverse osmosis purified water system to demonstrate that the company could “effectively control, maintain, sanitize, and monitor the system so it consistently produces pharmaceutical grade water that, at a minimum, meets the USP monograph for purified water.” Among other problems, the company failed to validate in-house assay methods and failed to demonstrate the antimicrobial effectiveness of the preservatives in its topical OTC drug products. Stability testing was also found to be inadequate.
Regarding API manufacture, FDA told the company, “You have not validated your manufacturing processes for dyclonine HCl or p-BUTAP. You failed to provide any validation documentation to demonstrate your processes are capable of operating within established parameters to assure batch uniformity, integrity, and consistent drug quality.” FDA also noted failure to establish and follow written cleaning and maintenance procedures for equipment, failure to establish controls for impurities, and failure to verify the suitability of analytical methods.
FDA found that the company had misbranded acne medications and sunscreens. “Absent an FDA-approved application, in order for OTC topical acne drug products to be legally marketed, they must conform to the conditions set forth in the final monograph for topical acne drug products set forth in 21 CFR Part 333, Subpart D,” wrote FDA. The agency determined that several of the company’s acne drug products did not fully comply with the monograph; some did not have an appropriate “uses” section and some failed to have appropriate warnings on the "Drug Facts" panels. Pharmco Laboratories’ sunscreens were also misbranded for multiple reasons, including misleading statements and missing directions for use.
FDA recommended that the company work with a consultant to comprehensively assess its facility, procedures, processes, laboratory controls, and quality management systems.