Sgarlato Laboratories – FDA Warning Letter, Jan 22, 2008

On August 27, 2008, the FDA issued a Warning Letter to Sgarlato Laboratories following an inspection from January 8-22, 2008, which found their Sgarlato Pain Free Pumps to be adulterated. The inspection revealed non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain procedures for acceptance of incoming product (21 CFR 820.80(b))**: Sgarlato Laboratories could not provide receiving inspection documentation for multiple lots of Pain Free Pumps, and for some lots, testing was explicitly not performed to fulfill orders. 2. **Failure to prevent distribution of expired devices (21 CFR 820.160(a))**: An expired Pain Free Pump kit (Lot 60772460) was shipped with the expiration date "blackened" out. 3. **Failure to control labeling activities (21 CFR 820.120(b))**: Labels with extended expiration dates were affixed over manufacturer's labels without justification. 4. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)(3))**: A complaint for a leaking pump lacked sufficient information to