Warning letter
Midlab Incorporated: warning letter of Feb 15, 2023
FDA warning letter 642374 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 642374 |
|---|---|
| Company | Midlab Incorporated |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 15, 2023 |
| Posted date | Mar 14, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 201.66(c)(2), 211.165(b), 211.166(a), 201.15, 201.128, 211.22, 211.34, 211.192, 330, 201.15(c), 201.62(a), 201.62(e) and 4 more |
| Inspection city | Athens |
| Inspection ZIP | 37303 |
| Inspection start date | Aug 1, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: