FDA WARNING_LETTER - Blue Ridge Pharmacy and Compounding Center - October 23, 2013

The FDA issued a Warning Letter to Blue Ridge Pharmacy and Compounding Center following an October 15-23, 2013 inspection. The firm produced drug products without valid prescriptions for individually-identified patients, rendering them misbranded (FDCA 502(f)(1)) and ineligible for statutory exemptions. Serious deficiencies in sterile drug production led to adulteration (FDCA 501(a)(2)(A)) due to insanitary conditions. Specific issues included non-sterile disinfectants/gloves, lack of sporicidal agents, inadequate instrument disinfection, no environmental monitoring, and an unclassified, carpeted glove box room lacking HEPA filtered air and cleanable surfaces. Significant Current Good Manufacturing Practice (CGMP) violations also caused adulteration (FDCA 501(a)(2)(B)). These included inadequate cleaning/disinfection (21 CFR 211.42(c)(10)(v)), lack of validated aseptic procedures (21 CFR 211.113(b)), insufficient environmental monitoring (21 CFR 211.42(c)(10)(iv)), poor equipment maintenance (21 CFR 211.42(c)(10)(vi)), no final product testing (21 CFR 211.167(a)), inadequate stability testing (21 CFR 211.166(a)), deficient air supply (21 CFR 211.42(c)(10)(iii)), and inappropriate personnel clothing (21 CFR 211.28(a)). The firm recalled sterile products and ceased sterile compounding. FDA recommended a comprehensive assessment and full 21 CFR Part 211 CGMP implementation before resuming production. A written response detailing corrective actions or confirming cessation was required within fifteen working days, with warnings of potential legal action.