Warning letter
Ajes Pharmaceuticals LLC: warning letter of Sep 9, 2016
FDA warning letter 494945 · New York District Office
Key facts
| Reference number | 494945 |
|---|---|
| Company | Ajes Pharmaceuticals LLC |
| Subject | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| Issue date | Sep 9, 2016 |
| Posted date | Sep 27, 2016 |
| Issuing office | New York District Office |
| Product type | Food/Cosmetics |
| CFR sections cited | 111, 111.70(b)(1), 111.70(b)(2), 111.70(e), 111.83(a), 111.83(b), 111.83(b)(1), 111.83(b)(2), 111.83(b)(3), 111.83(b)(4), 111.75(a), 111.75(c) and 1 more |
| Inspection city | Copiague |
| Inspection ZIP | 11726 |
| Inspection start date | Feb 23, 2016 |
| Letter on fda.gov | web.archive.org |
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: