FDA WARNING_LETTER - Nature's Pharmacy & Compounding Center - November 22, 2013

From November 12-22, 2013, an FDA inspection of Nature's Pharmacy & Compounding Center identified serious deficiencies. The firm was producing drug products without valid prescriptions for individually-identified patients, violating Section 503A of the FDCA and the agency's Compliance Policy Guide 460.200. This renders these drugs misbranded under Section 502(f)(1) of the FDCA.

Furthermore, the inspection revealed insanitary conditions for sterile drug production, leading to adulteration under Section 501(a)(2)(A) of the FDCA. Examples include mixing sterile lidocaine with non-sterile lubricant without further sterilization, failure to demonstrate adequate protection from the (b)(4) for sterile processing, and not using sterile disinfectants. A voluntary recall of sterile products occurred on November 13, 2013, due to sterility assurance issues.

Since the firm manufactured and distributed drugs without individual prescriptions, they are subject to CGMP regulations (21 CFR Parts 210 and 211). Significant CGMP violations were observed, causing these drugs to be adulterated under Section 501(a)(2)(B) of the FDCA. Violations included failure to establish procedures for preventing microbiological contamination (21 CFR 211.113(b)), inadequate cleaning/disinfection systems (21 CFR 21