Warning letter
Custom Research Labs Inc.: warning letter of Jul 8, 2022
FDA warning letter 616184 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 616184 |
|---|---|
| Company | Custom Research Labs Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 8, 2022 |
| Posted date | Jul 26, 2022 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 201.128, 211.22, 211.34, 310.545, 330, 330.1, 330.3, 201.66(b)(2), 210.3(b)(7), 210.3(b)(8), 211.84(d)(1), 211.100(a) and 6 more |
| Inspection city | Gardena |
| Inspection ZIP | 90248 |
| Inspection start date | Jun 1, 2021 |
| 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: