FDA WARNING_LETTER - Oakdell Pharmacy, LLC - March 01, 2013

The FDA issued a Warning Letter to Oakdell Pharmacy, Inc. following inspections in 2013 and 2014, revealing the firm produced drug products without valid prescriptions for individually-identified patients. This practice means these drugs do not qualify for exemptions under FDCA Section 503A and are misbranded under section 502(f)(1) due to inadequate directions for use. Serious deficiencies in sterile drug product practices were also observed, including insanitary conditions like porous workbenches and poor aseptic technique, causing sterile products to be adulterated under section 501(a)(2)(A).

Additionally, significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211) led to adulteration under section 501(a)(2)(B). These included failures in personnel clothing (21 CFR 211.28(a)), equipment maintenance for aseptic conditions (21 CFR 211.42(c)(10)(vi)), environmental monitoring (21 CFR 211.42(c)(10)(iv)), written procedures for preventing microbiological contamination and process validation (21 CFR 211.113(b)), cleaning/disinfecting systems (21 CFR 211.42(c)(10)(v)), and unsupported expiration dates (21 CFR 211.137(a)).

FDA mandates a comprehensive assessment of operations, especially aseptic processing, with a third-party consultant recommended, to implement 21 CFR Part 211 compliant corrections and address misbranding. Failure to correct these violations promptly may result in legal action. A written response detailing corrective actions is required within fifteen working days.