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FDA establishment 3008492337, Tiffin, Ohio, United States. Part of American Contract Systems's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 5
Official action indicated: 3
Last inspection ended: Jun 2, 2025
Warning letters: 1
Recalls since 2016: 8
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 820.60. Identification procedures, Lack of or inadequate procedures Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been adequately established.
21 CFR 820.250(b). Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been adequately established.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.30(j). Design history file The design history file was not established and does not demonstrate that the design was developed following the approved design plan.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
21 CFR 820.75(a). Documentation Process validation activities and results have not been adequately documented.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.80(e). Documentation Acceptance activities were not adequately documented.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.90(b)(2). Product rework procedures, Lack of or inadequate procedures Procedures for rework of nonconforming product have not been adequately established.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Tiffin, Ohio, United States. Part of