Nora Apothecary Pharmacy – FDA Warning Letter, Mar 21, 2013

On February 14, 2014, the FDA issued a Warning Letter to Nora Apothecary and Alternative Therapies, Inc. following inspections from March 19-21, 2013, and a follow-up on May 14-15, 2013. The inspection revealed the firm was producing drug products without valid prescriptions for individually-identified patients and had serious deficiencies in sterile drug product manufacturing, leading to a recall of sterile products produced before April 19, 2013.

Key violations included an ISO-5 aseptic processing area located in an unclassified room, an unclassified gowning room, and improper manual manipulations within the ISO-5 area, risking microbial contamination. These conditions rendered sterile drug products adulterated under FDCA Section 501(a)(2)(A).

Furthermore, drugs compounded without individual patient prescriptions were deemed misbranded under Section 502(f)(1) and subject to CGMP regulations (21 CFR Parts 210 and 211). Significant CGMP violations included failure to establish procedures to prevent microbiological contamination (21 CFR 211.113(b)), inadequate stability testing (21 CFR 211.166(a)), lack of final product conformance testing (21 CFR 211.167(a)), inadequate environmental monitoring (21 CFR 211.