Premier Pharmacy Labs Inc – FDA Warning Letter, May 9, 2014

On April 27, 2015, the FDA issued a Warning Letter to Premier Pharmacy Labs, Inc. (dba Rx Nations) following an inspection from April 10 to May 9, 2014. The facility, registered as an outsourcing facility under FDCA section 503B, was cited for serious deficiencies in sterile drug product production, posing patient risks.

Key violations include: - **Insanitary Conditions & Adulteration (501(a)(2)(A), 501(b), 501(a)(2)(B) FDCA):** Failure to monitor air pressure differentials in ISO 7 areas, infrequent personnel monitoring, and inadequate demonstration of hood protection for ISO 5 areas. An injectable drug product (Multi Trace 4 Concentrate P.F. INJ) was found adulterated due to particulate matter (crimp cap material), falling below USP standards. - **CGMP Violations (21 CFR Parts 210 & 211):** Inadequate equipment maintenance for aseptic conditions, insufficient environmental monitoring, failure to investigate batch failures, inappropriate personnel clothing, inadequate facility design to prevent contamination, and lack of written standards for cleaning/sterilization. - **Failure to Meet 503B Conditions:** Labels lacked "This is a compounded drug" statement, containers omitted adverse event reporting information, and active/inactive ingredients were not listed on labels/