FDA WARNING_LETTER - Prosec Protection Systems, Inc. - December 22, 2011

On December 2, 2011, the FDA inspected Prosec Protection Systems, Inc. in Lakewood, New Jersey, and found that their My Child Identification Kit, a medical device, was adulterated. The inspection revealed that the company's manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish finished device acceptance procedures (21 CFR 820.80(d)):** No pass/fail results were recorded for sterilization records, and sterilization cycle reports were unsigned and contained mismatched parameters. 2. **Failure to validate processes (21 CFR 820.75(a)):** Sterilization validation protocols lacked critical parameters (time, temperature, pressure, plasma, gas concentration), validation runs were not consecutive, and a failed interim run was not investigated. Protocols were also not signed by management prior to validation. 3. **Failure to establish procedures for monitoring and control of process parameters (21 CFR 820.75(b)):** Sterility testing procedures did not include positive growth controls, and biological indicators were not placed horizontally as per manufacturer instructions. 4. **Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** No written SOP for documenting CAPAs in the software system