Asept Pak Inc. – FDA Warning Letter, Jun 20, 2012

On August 7, 2012, the FDA issued a Warning Letter to Asept Pak Inc. following an inspection from June 11-20, 2012, at their Malone, New York facility. The inspection determined that Asept Pak Inc. manufactures Sterile Sodium Chloride 0.9% USP for wound irrigation and Sterile Sodium Chloride 0.9% for device irrigation, which are classified as devices under the Federal Food, Drug, and Cosmetic Act.

The inspection revealed that these devices are adulterated because the manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to adequately document corrective and preventive action activities and results (21 CFR 820.100(b))**: For example, no investigation was initiated or documented for a microorganism (Bacillus clausii) found in an initial sample of Sterile Sodium Chloride 0.9% USP for wound irrigation, Lot ANR, Batch F11110, despite subsequent retests yielding sterile results. 2. **Failure to include design validation results in the Design History File (DHF) (21 CFR 820.30(g))**: The DHF for Sterile Sodium Chloride 0.9% for wound irrigation lacked documentation of design validation, including actual or simulated use conditions