FDA WARNING_LETTER - Triangle Compounding - March 01, 2013

From February 19 to March 1, 2013, an FDA inspection of Triangle Compounding Pharmacy identified serious deficiencies. The firm was producing drug products without valid prescriptions for individually-identified patients, violating Section 503A of the FDCA and rendering these drugs unapproved new drugs and misbranded under Sections 505(a) and 502(f)(1) of the FDCA.

Furthermore, the inspection revealed insanitary conditions in sterile drug production, causing all sterile products to be adulterated per Section 501(a)(2)(A) of the FDCA. Specific issues included a (b)(4) hood near a window with blinds, a non-cleanable wall surface with a ledge, and an operator shaking the hood during aseptic filling. The firm also improperly invalidated a failed sterility test result for a batch.

For drugs compounded without individual prescriptions, the firm is subject to CGMP regulations (21 CFR Parts 210 and 211), and significant violations were observed, leading to adulteration under Section 501(a)(2)(B). These violations included failure to investigate discrepancies (21 CFR 211.192), inadequate stability testing (21 CFR 211.166(a)), insufficient procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate equipment maintenance for aseptic conditions (