Warning letter
Aplicare, Inc.: warning letter of Dec 15, 2016
FDA warning letter 489281 · New England District Office
Key facts
| Reference number | 489281 |
|---|---|
| Company | Aplicare, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 15, 2016 |
| Posted date | Dec 15, 2016 |
| Issuing office | New England District Office |
| Product type | Drugs |
| CFR sections cited | 333.250, 211.42(c), 211.46(c), 211.166(a), 211.113(b), 211.34, 333.201, 333.210 |
| Inspection city | Meriden |
| Inspection ZIP | 06450 |
| Inspection start date | Dec 14, 2015 |
| Letter on fda.gov | web.archive.org |
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: