Warning letter
HNC Products Inc.: warning letter of Sep 10, 2020
FDA warning letter 607359 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 607359 |
|---|---|
| Company | HNC Products Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Sep 10, 2020 |
| Posted date | Sep 22, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| CFR sections cited | 211.192, 207, 210, 211.34, 207.41(c)(1), 207.41(c)(2), 211.22(a), 211.100(a) |
| Inspection city | Clinton |
| Inspection ZIP | 61727 |
| Inspection start date | Mar 10, 2020 |
| 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: