Warning letter
Tender Corporation: warning letter of Jul 23, 2020
FDA warning letter 599789 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 599789 |
|---|---|
| Company | Tender Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 23, 2020 |
| Posted date | Jul 28, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.198(a), 201.61, 201.128, 211.34, 211.192, 201.66(b)(2), 347, 211.194(a), 347.50(a)(1), 211.160(b) |
| Inspection city | Littleton |
| Inspection ZIP | 03561 |
| Inspection start date | Nov 12, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: