Warning letter
Cross Brands Contract Filling, LLC: warning letter of Dec 17, 2019
FDA warning letter 589295 · Office of Pharmaceutical Quality
Key facts
| Reference number | 589295 |
|---|---|
| Company | Cross Brands Contract Filling, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 17, 2019 |
| Posted date | Dec 31, 2019 |
| Issuing office | Office of Pharmaceutical Quality |
| Product type | Drugs |
| CFR sections cited | 211.84(d)(1), 201.128, 211.22, 347, 211.84(d)(6) |
| Inspection city | West Melbourne |
| Inspection ZIP | 32904 |
| Inspection start date | Jun 6, 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: