Warning letter
Sal Pharma: warning letter of Apr 20, 2017
FDA warning letter 516205 · Center for Drug Evaluation and Research
Key facts
| Reference number | 516205 |
|---|---|
| Company | Sal Pharma |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded |
| Issue date | Apr 20, 2017 |
| Posted date | May 2, 2017 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.1(h)(2) |
| Inspection city | Hyderabad |
| Inspection start date | Jun 27, 2016 |
| 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: