Warning letter
Grace Analytical Lab Inc: warning letter of Nov 19, 2019
FDA warning letter 586510 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 586510 |
|---|---|
| Company | Grace Analytical Lab Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 19, 2019 |
| Posted date | Jan 7, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 211.22(d), 211.68(b), 211.160(b), 211.194(a), 211.165(e) |
| Inspection city | Berkeley |
| Inspection ZIP | 60163 |
| Inspection start date | May 8, 2019 |
| 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: