Warning letter
American Contract Systems: warning letter of Nov 6, 2018
FDA warning letter 568066 · New England District Office
Key facts
| Reference number | 568066 |
|---|---|
| Company | American Contract Systems |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 6, 2018 |
| Posted date | Nov 20, 2018 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Zelienople |
| Inspection ZIP | 16063 |
| Inspection start date | Sep 18, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: