FDA EIR - Ferndale Laboratories, Inc. - March 04, 2022

Ferndale Laboratories, Inc., a contract manufacturer of topical drug products, underwent a routine FDA inspection from February 22 to March 4, 2022. The inspection, covering quality, facilities, equipment, materials, production, and laboratory systems, identified three significant observations requiring corrective action, leading to the issuance of an FDA Form 483. The primary issues centered on deficiencies in the company's Quality Unit authority and investigation processes, as well as discrepancies in microbiology procedures. Firstly, the Quality Unit lacked independent authority to fully investigate errors, particularly for contract-manufactured products, delaying comprehensive investigations until customer approval was received, contrary to Good Manufacturing Practices (21 CFR §211.22(a)). Secondly, several investigations were deemed inadequate (21 CFR §211.192). This included a failure to thoroughly investigate stability failures of Hydrocortisone butyrate cream, not fully understanding container interaction mechanisms, and not extending the investigation scope to similar products. Additionally, an unexplained discrepancy between failing stability samples and passing retain samples for one lot was not investigated. The company also failed to assess the impact of an out-of-specification excipient on previously released finished products following a regulatory monograph update. Finally, procedures for preventing objectionable microorganisms in non-sterile drug products did not accurately reflect actual laboratory practices, where all microbial growths from water sampling underwent identification, contrary to the documented procedure (21 CFR §211.113(a)). Ferndale Laboratories management acknowledged the observations and committed to providing a written response with proposed corrections within 15 business days.