FDA EIR - BMC 1092, Inc. - September 28, 2016

An FDA inspection of BMC 1092, Inc. dba Solo Laboratories, Inc., a contract manufacturer of OTC topical drugs and cosmetics, was conducted from September 14 to September 28, 2016. The inspection, carried out under drug manufacturing and cosmetic programs, identified significant deficiencies in the company's adherence to current Good Manufacturing Practices (cGMP).

Three main observations were cited. Firstly, the firm lacked adequate procedures to prevent objectionable microorganisms in non-sterile drug products, evidenced by 18 instances of high microbial counts in the water system without investigation, insufficient water sampling protocols, undocumented sanitization contact times, and an uncontrolled water point-of-use. Secondly, the stability program for drug products was found deficient, specifically lacking microbiological testing and analysis of preservative content for various OTC products like sunscreen and dandruff shampoo. Thirdly, the company's change control procedures were inadequate; they were limited to documents and did not cover changes to facilities, equipment, material handling, or production systems, nor did they require prospective review or effectiveness evaluation for validated processes.

These issues represent non-compliance with regulations such as 21 CFR 211.113(a), 21 CFR 211.166(a)(3), and 21 CFR 211.100(a). Management, led by President Brian D. Corcoran, acknowledged the findings and committed to implementing immediate corrections, promising a written response to the FDA within 15 business days.