Warning letter
Blaine Labs Inc: warning letter of May 5, 2020
FDA warning letter 598733 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 598733 |
|---|---|
| Company | Blaine Labs Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 5, 2020 |
| Posted date | May 19, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 347, 211.34, 211.22(a), 201.128, 211.84(d)(6), 211.100(a), 358, 211.192 |
| Inspection city | Santa Fe Springs |
| Inspection ZIP | 90670-4634 |
| Inspection start date | Sep 25, 2019 |
| 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: