Warning letter
Divi's Laboratories Ltd. (Unit II): warning letter of Apr 13, 2017
FDA warning letter 518434 · Center for Drug Evaluation and Research
Key facts
| Reference number | 518434 |
|---|---|
| Company | Divi's Laboratories Ltd. (Unit II) |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection |
| Issue date | Apr 13, 2017 |
| Posted date | Apr 25, 2017 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 314.420 |
| Inspection city | Visakhapatnam District |
| Inspection start date | Nov 29, 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: