FDA WARNING_LETTER - Encompas Unlimited, Inc. - November 18, 2014

On February 20, 2015, the FDA issued a Warning Letter to Encompas Unlimited, Inc. following an inspection from November 10-18, 2014, which found their medical devices (50 Endo Scrub, Adult Best Bite Block, Atypia Upper Endoscopy Headrest, Endoscopy Wedge) to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to adequately establish and maintain CAPA procedures (21 CFR 820.100(a))**: Procedures lacked requirements for verifying/validating actions and investigating problem causes. This was a repeat observation from March 3, 2011. 2. **Failure to maintain complaint files and procedures (21 CFR 820.198(a))**: Procedures did not ensure evaluation for Medical Device Report (MDR) requirements. 3. **Failure to establish procedures for receiving or finished product acceptance (21 CFR 820.80)**: Inadequate procedures for receiving inspection of components, a repeat observation. 4. **Failure to adequately establish procedures to control nonconforming product (21 CFR 820.90(a))**: Procedures for nonconforming ES-50