FDA Inspection
American Contract Systems IncAmerican Contract Systems Inc – FDA Inspection, Jun 2, 2025
Record Details
This FDA Inspection record concerns American Contract Systems Inc, with an inspection on June 2, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
- Inspection Date
- June 2, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · cbf08729-04fd-48b8-99fb-5ed27693b443
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1271788
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of American Contract Systems Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 14, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for American Contract Systems Inc
- FDA Inspection 1246895 - 2024-08-14
- FDA Inspection 1011028 - 2017-04-27
- FDA Inspection 754154 - 2011-11-22
- FDA Inspection 705754 - 2011-01-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.