FDA WARNING_LETTER - American Contract Systems, Inc. - October 04, 2019

The FDA conducted an inspection of American Contract Systems, Inc., a medical device manufacturer and contract sterilizer, from September 9 to October 4, 2019. The inspection revealed that the firm's surgical trays/kits are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820). Key violations include the failure to adequately validate sterilization processes (21 CFR 820.75(a)), establish and maintain procedures for monitoring process parameters (21 CFR 820.75(b)), document the review and evaluation of process changes or deviations (21 CFR 820.75(c)), adequately validate computer software used in production (21 CFR 820.70(i)), and adequately maintain device master records (21 CFR 820.181), which was a repeat observation. The FDA requires a written response within fifteen business days detailing specific corrections, preventive actions, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments. The firm must address systemic problems and ensure overall compliance with FDA regulations.