Warning letter
Regenerative Processing Plant, LLC: warning letter of Aug 16, 2024
FDA warning letter 672154 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 672154 |
|---|---|
| Company | Regenerative Processing Plant, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 16, 2024 |
| Posted date | Sep 6, 2024 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.188(b)(3), 207.1, 211.34, 312, 207.77(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.84(d)(1), 211.94(b), 211.113(b), 211.166(a), 200.50(a)(2) and 5 more |
| Inspection city | Palm Harbor |
| Inspection ZIP | 34684 |
| Inspection start date | Jun 20, 2023 |
| 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: