Warning letter
Kalchem International, Inc.: warning letter of Aug 27, 2020
FDA warning letter 607098 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 607098 |
|---|---|
| Company | Kalchem International, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 27, 2020 |
| Posted date | Sep 15, 2020 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 201.18, 201.128, 210, 211.34, 347, 211.165(a), 201.66(d)(7) |
| Inspection city | Lindsay |
| Inspection ZIP | 73052 |
| Inspection start date | Feb 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: