Warning letter
Boothwyn Pharmacy LLC: warning letter of Jul 25, 2018
FDA warning letter 560524 · New Jersey District Office
Key facts
| Reference number | 560524 |
|---|---|
| Company | Boothwyn Pharmacy LLC |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Jul 25, 2018 |
| Posted date | Jul 25, 2018 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 200.10(b), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.68(a), 211.113(b), 211.166(a), 211.167(a), 210.1(b) |
| Inspection city | Kennett Square |
| Inspection ZIP | 19348 |
| Inspection start date | Jun 5, 2017 |
| 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: