Warning letter
Monarch PCM, LLC: warning letter of Jun 10, 2022
FDA warning letter 620779 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 620779 |
|---|---|
| Company | Monarch PCM, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 10, 2022 |
| Posted date | Jun 28, 2022 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 330, 207.41(c)(2), 201.128, 207.49, 207.57, 211.22, 211.34, 211.63, 211.192 |
| Inspection city | Fort Worth |
| Inspection ZIP | 76118 |
| Inspection start date | Jun 7, 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: