Warning letter
Marcus Research Laboratory, Inc.: warning letter of Sep 30, 2021
FDA warning letter 615153 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 615153 |
|---|---|
| Company | Marcus Research Laboratory, Inc. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Sep 30, 2021 |
| Posted date | Oct 19, 2021 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| Inspection city | Saint Louis |
| Inspection ZIP | 63103 |
| Inspection start date | May 3, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: