Warning letter
Teligent Pharma, Inc.: warning letter of Nov 26, 2019
FDA warning letter 587592 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 587592 |
|---|---|
| Company | Teligent Pharma, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 26, 2019 |
| Posted date | Dec 10, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.100(a), 211.166(a), 211.198(a), 314.81(b)(1), 314.81(b)(1)(i), 314.81(b)(1)(ii) |
| Inspection city | Buena |
| Inspection ZIP | 8310 |
| Inspection start date | Apr 22, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: