Warning letter
BioLab Sciences, Inc.: warning letter of Aug 23, 2022
FDA warning letter 621465 · Office of Biological Products Operations – Division 2
Key facts
| Reference number | 621465 |
|---|---|
| Company | BioLab Sciences, Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Aug 23, 2022 |
| Posted date | Sep 20, 2022 |
| Issuing office | Office of Biological Products Operations – Division 2 |
| Product type | Biologics |
| CFR sections cited | 211.84, 211.192, 312, 211.42(c)(10)(i), 211.56(b), 211.67(b), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 1271, 1271.15 and 8 more |
| Inspection city | Mesa |
| Inspection ZIP | 85202 |
| Inspection start date | Aug 23, 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: