FDA WARNING_LETTER - Forcemech International LLC - April 04, 2022

On September 21, 2022, the FDA issued a Warning Letter to Forcemech Navigator and Navigator XL Powered Wheelchair, following an inspection from March 28 to April 4, 2022. The firm, a medical device manufacturer (repackager/relabeler) and initial distributor/importer, was found to have adulterated devices under 21 U.S.C. §351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to adequately maintain a device master record (DMR) with packaging and labeling specifications (21 CFR 820.181(d)). 2. Failure to establish and maintain procedures for controlling labeling activities, specifically for new serial number tracking (21 CFR 820.120). 3. Failure to adequately establish procedures for acceptance activities, with incomplete product acceptance/release criteria in the Final Acceptance Inspection procedure (21 CFR 820.80(a)). 4. Failure to adequately establish and maintain document control procedures, lacking revision history for user manuals and label control (21 CFR 820.40). 5. Failure to adequately establish procedures for servicing activities and verifying service meets requirements, particularly for distributing and installing replacement parts (21 CFR 8