FDA WARNING_LETTER - Oregon Compounding Centers, Inc. - August 28, 2014

An FDA inspection of a facility in Wilsonville, Oregon, from August 4-28, 2014, revealed significant violations. The firm was found to be producing drug products without valid prescriptions for individually-identified patients and manufacturing domperidone drug products. Domperidone is not subject to an applicable USP/NF monograph, is not a component of an FDA-approved human drug, and is not on a Secretary-developed list, thus rendering products containing it ineligible for exemptions under FDCA Section 503A.

Serious deficiencies in sterile drug product manufacturing were observed, including inadequate disinfection of equipment and materials entering the ISO 5 area, operators with exposed skin, and failure to demonstrate adequate protection of the ISO 5 area by hoods. These conditions pose a significant contamination risk, leading to the classification of sterile products as adulterated under FDCA Section 501(a)(2)(A).

Drugs compounded without valid prescriptions or containing domperidone are considered misbranded under FDCA Section 502(f)(1) due to lacking adequate directions for use. Furthermore, the firm's manufacturing of these drugs is subject to FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), and significant CGMP violations were noted, including failures in cleaning/disinfection systems, aseptic process validation, personnel gowning, environmental monitoring, stability testing, and investigation of discrepancies. These