FDA WARNING_LETTER - KeyMed (Medical and Industrial Equipment) Ltd. - October 25, 2007

On October 22-25, 2007, an FDA inspection of KeyMed, Ltd. in Southend-On-Sea, Essex, revealed that their mobile workstations for endoscopes and suction pumps were adulterated under 21 U.S.C. 351(h). The manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

KeyMed's responses dated November 7, 8, 28, 2007, and January 15, 2008, were deemed inadequate for most violations. Deficiencies included: 1. Failure to establish and maintain design control procedures for suction pumps (21 CFR 820.30(a)(1)), specifically for Design Verification, Design Validation, and Design Changes. 2. Failure to establish and maintain a corrective and preventive action (CAPA) procedure that includes analyzing various quality data sources to identify nonconforming product causes and verifying/validating CAPA effectiveness (21 CFR 820.100(a)(1)). 3. Failure to establish and maintain procedures for identifying, documenting, validating/verifying, reviewing, and approving design changes before implementation (21 CFR 820.30(i)), exemplified by undocumented "concessions" leading to duplicate changes.