Complete batch records are a fundamental source of information, the FDA tells Airgas CEO Peter McCausland in a warning letter. "It is essential to document each significant step (e.g., pre- and post-fill checks) of each batch of medical gases," should the need arise to investigate complaints and product defects.
The letter, which follows the July inspection of a company facility in Tennessee, cites Airgas for failing to document "each significant step" in batch production. Inspectors found the records lacking for certain filling operations.
Workers had failed to document pre- and post-fill cylinder checks, including the finished product assay test. The company said in its response to the initial inspection report that it would train employees in "all applicable cGMP requirements." But the regulator says in the warning letter that the company needs to provide specifics of the training.
Airgas was cited also for the incomplete investigation of a batch failure. Following the return of a contaminated nitrogen NF cylinder, the company investigated the lot and recalled the remaining cylinders. But following discussion with FDA, Airgas expanded the investigation and, ultimately, the recall to include all medical gas products.