Warning letter
Tec Laboratories Inc: warning letter of Mar 20, 2019
FDA warning letter 568666 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 568666 |
|---|---|
| Company | Tec Laboratories Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 20, 2019 |
| Posted date | Apr 2, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.165(b), 201.128, 347, 347.20(d), 347.20(c) |
| Inspection city | Albany |
| Inspection ZIP | 97321-5968 |
| Inspection start date | Jul 9, 2018 |
| 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: