Warning letter
Re-Gen Active Lab, Inc.: warning letter of May 27, 2022
FDA warning letter 620763 · Office of Biological Products Operations – Division 2
Key facts
| Reference number | 620763 |
|---|---|
| Company | Re-Gen Active Lab, Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | May 27, 2022 |
| Posted date | Jun 28, 2022 |
| Issuing office | Office of Biological Products Operations – Division 2 |
| Product type | Biologics |
| CFR sections cited | 211.188(b), 312, 211.56(b), 211.67(b), 211.68(a), 211.80(a), 211.100(a), 211.113(b), 211.166(a), 211.165(e), 610.12, 1271 and 7 more |
| Inspection city | Irving |
| Inspection ZIP | 75038 |
| Inspection start date | Jul 19, 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: