Warning letter
High Chemical Company, Div of National Generic Distributors: warning letter of Jul 2, 2019
FDA warning letter 576577 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 576577 |
|---|---|
| Company | High Chemical Company, Div of National Generic Distributors |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Jul 2, 2019 |
| Posted date | Jul 23, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 201.122 |
| Inspection city | Levittown |
| Inspection ZIP | 19056 |
| Inspection start date | Dec 17, 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: