Warning letter
Kingston Pharma LLC: warning letter of May 14, 2019
FDA warning letter 572904 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 572904 |
|---|---|
| Company | Kingston Pharma LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | May 14, 2019 |
| Posted date | Jun 4, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 201.15, 201.128, 201.326, 211.34, 211.58, 211.22(d), 211.100(a) |
| Inspection city | Massena |
| Inspection ZIP | 13662 |
| Inspection start date | Nov 13, 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: