FDA WARNING_LETTER - Wexford Labs Inc - December 21, 2012

On November 27 through December 21, 2012, an FDA inspection of Wexford Labs Inc. in Kirkwood, MO, revealed that their disinfectant products, including Wex-Cide 128, are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods and controls do not conform to the current Good Manufacturing Requirements (cGMP) of the Quality System Regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish acceptance criteria (21 CFR 820.80(a)):** The firm uses returned product in subsequent batches of Wex-Cide 128 without a procedure, routine testing, or established acceptance criteria. Notably, returned product that failed specifications for ortho-phenylphenol was used. The firm's response was inadequate as it lacked justification for this practice. 2. **Inadequate device history records (21 CFR 820.184):** Device history records for Class I devices, including Wex-Cide 128, lacked essential information such as dates of manufacture, quantity manufactured, quantity released, acceptance records, and primary identification/labeling. There was also no documentation of review and approval by appropriate individuals. The firm's response was inadequate, failing to specify training/qualifications for reviewers or validate the determined