FDA WARNING_LETTER - SCA Pharmaceuticals, LLC - April 01, 2014

The FDA issued a Warning Letter to SCA Pharmaceuticals, LLC, an outsourcing facility, following an inspection from March 17 to April 1, 2014. The inspection revealed serious deficiencies in sterile drug production practices, including inadequate investigations of sterility failures, particulates, and out-of-specification pressure differentials, as well as insufficient environmental monitoring and endotoxin testing. The firm also failed to meet conditions under section 503B of the FDCA, rendering its compounded drugs ineligible for certain exemptions.

Specific violations included: drug products lacking required label statements (e.g., "This is a compounded drug"), failure to submit required drug product reports to FDA, and significant CGMP violations. CGMP deficiencies included failure to thoroughly investigate discrepancies (21 CFR 211.192), inadequate environmental monitoring systems (21 CFR 211.42(c)(10)(iv)), and lack of appropriate laboratory determination for sterile/pyrogen-free products (21 CFR 211.167(a)). Additionally, drug products were misbranded due to a lack of adequate directions for use (section 502(f)(1)) and false labeling (section 502(a)), exemplified by a voluntary recall of Glycopyrrolate Injection with an unclear expiration date.

FDA found the firm's proposed corrective actions partially deficient, particularly regarding sterility testing methods and environmental monitoring. The letter strongly recommends a comprehensive assessment of operations, possibly with a third-party consultant, to ensure compliance with quality standards. Failure to promptly correct these violations may result in legal action, including seizure and injunction, and FDA intends to re-inspect the facility. A written response detailing corrective actions is required within fifteen working days.