FDA WARNING_LETTER - Jajco, Inc. DBA Anchor Drugs Pharmacy - June 03, 2016

On August 22, 2017, the FDA issued a Warning Letter to Jajco, Inc. dba Anchor Drugs Pharmacy following an inspection from May 20 to June 3, 2016. The inspection revealed that the firm produced drug products that failed to meet the conditions for exemption under Section 503A of the FDCA, specifically by not receiving valid prescriptions for individually-identified patients for a portion of its compounded drugs. This renders these "ineligible drug products" subject to FDA approval, adequate labeling requirements, and Current Good Manufacturing Practices (CGMP).

The letter cited serious deficiencies in sterile drug product production, leading to adulterated drugs under FDCA Section 501(a)(2)(A) due to insanitary conditions. Examples include poor aseptic practices (bare hands in ISO 5 hood), insufficient sporicidal agent contact time, inadequate pressure differentials in cleanrooms, improper air return vent placement, and failure to demonstrate adequate protection of the ISO 5 area.

Furthermore, the ineligible drug products were found to be adulterated under Section 501(a)(2)(B) due to significant CGMP violations, including: 1. Failure to establish and follow written procedures for preventing microbiological contamination and validating aseptic processes (21 CFR 211.113(b)). 2. Failure to establish adequate HEPA-filtered air supply under positive pressure in aseptic areas (21