Warning letter
Americare Compounding, LLC.: warning letter of Apr 22, 2014
FDA warning letter 410158 · New York District Office
Key facts
| Reference number | 410158 |
|---|---|
| Company | Americare Compounding, LLC. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 22, 2014 |
| Posted date | Apr 28, 2014 |
| Issuing office | New York District Office |
| Product type | Drugs |
| CFR sections cited | 211.167(a), 201.115, 210, 211, 211.42, 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.165(a), 211.166(a) |
| Inspection city | Garden City South |
| Inspection ZIP | 11530 |
| Inspection start date | Jun 3, 2013 |
| 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: