Warning letter
Fallon Wellness Pharmacy, L.L.C.: warning letter of Feb 1, 2016
FDA warning letter 485889 · New York District Office
Key facts
| Reference number | 485889 |
|---|---|
| Company | Fallon Wellness Pharmacy, L.L.C. |
| Subject | CGMP/Compounded Drugs/Misbranding |
| Issue date | Feb 1, 2016 |
| Posted date | Aug 9, 2016 |
| Issuing office | New York District Office |
| Product type | Drugs |
| CFR sections cited | 211.167(a), 211, 211.42, 211.28(a), 211.42(c)(10)(vi), 211.113(b), 211.166(a), 201.115 |
| Inspection city | Latham |
| Inspection ZIP | 12110 |
| Inspection start date | Mar 2, 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: