Warning letter
Westlake IVF, LLC: warning letter of Sep 30, 2019
FDA warning letter 590113 · Office of Biological Products Operations - Division 2
Key facts
| Reference number | 590113 |
|---|---|
| Company | Westlake IVF, LLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Sep 30, 2019 |
| Posted date | Oct 15, 2019 |
| Issuing office | Office of Biological Products Operations - Division 2 |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.75, 1271.155, 1271.47(a), 1271.75(a)(1), 1271.3(r)(2), 1271.50(a), 1271.60(a), 1271.85(a), 1271.90(b), 1271.90(c) |
| Inspection city | Austin |
| Inspection ZIP | 78746 |
| Inspection start date | May 20, 2019 |
| 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: