Warning letter
Louisville Reproductive Center: warning letter of Aug 29, 2017
FDA warning letter 533267 · Los Angeles District Office
Key facts
| Reference number | 533267 |
|---|---|
| Company | Louisville Reproductive Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Aug 29, 2017 |
| Posted date | Oct 10, 2017 |
| Issuing office | Los Angeles District Office |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.75, 1271.3(s), 1271.75(a), 1271.90(b), 1271.90(c) |
| Inspection city | Louisville |
| Inspection ZIP | 40207 |
| Inspection start date | Jun 7, 2017 |
| 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: