FDA WARNING_LETTER - OKC Allergy Supplies, Inc. - April 26, 2013

The FDA conducted an inspection of Allergy Laboratories, Inc. in Oklahoma City from April 16 to April 26, 2013, documenting significant deviations from current good manufacturing practice (CGMP) requirements for licensed biological and pharmaceutical drug products. These deviations violate Section 501(a)(2)(B) of the FD&C Act, Section 351 of the PHS Act, and 21 CFR Parts 210, 211, and 600. Key deficiencies include the failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192), failure to establish and follow procedures to prevent microbiological contamination and validate aseptic processes (21 CFR 211.113(b)), failure to routinely calibrate equipment (21 CFR 211.68(a)), failure to assure non-reactive drug product containers/closures (21 CFR 211.94 and 600.11(h)), and failure to document significant steps in batch records (21 CFR 211.188(b)). The FDA noted that the firm's quality control unit failed to assure product identity, strength, quality, and purity, indicating an extensive lack of control over manufacturing processes. The Agency lacks confidence in the firm's ability to manufacture safe and effective products. Allergy Laboratories, Inc. must undertake a comprehensive assessment to achieve CGMP compliance, including thorough investigations and effective corrective and preventive actions. A written response detailing corrective steps and timelines is required within 15 working days. Failure to correct these deviations may lead to regulatory actions such as license suspension, seizure, or injunction, and may impact federal contracts.