Airgas, Inc. – FDA Warning Letter, Jul 19, 2010

The FDA issued a Warning Letter to Airgas, Inc. following a July 2010 inspection of their medical gas manufacturing facility, Airgas South, Inc., in Chattanooga, Tennessee. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations:** The firm failed to thoroughly investigate a contaminated Nitrogen NF cylinder (lot WC01X153A) complaint. Initial investigation was limited to one lot, but FDA intervention led to an expanded investigation and recall of all medical gas products within expiry. 2. **Incomplete Batch Records:** Between April 2009 and June 2010, the firm filled medical gas batches without preparing or completing batch production records. Critical pre- and post-fill checks (e.g., dead ring test, odor check, leak test, residual gas removal, finished product assay) were not documented. The proposed corrective action of general CGMP training was deemed insufficient. 3. **Deficient Test Procedures:** The firm failed to appropriately conduct pre-fill odor tests. Employees were observed painting cylinders immediately before odor testing, with paint fumes potentially interfering with contamination detection. The proposed corrective action lacked details on drying time and implementation date.

The FDA found the firm's July 30, 2010, response