Warning letter
Pharmcore Inc. dba Hallandale Pharmacy: warning letter of Mar 11, 2020
FDA warning letter 605569 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 605569 |
|---|---|
| Company | Pharmcore Inc. dba Hallandale Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Mar 11, 2020 |
| Posted date | Mar 31, 2020 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 201.115, 200.10(b), 211.42(c), 210.1(b) |
| Inspection city | Fort Lauderdale |
| Inspection ZIP | 33312 |
| Inspection start date | Jul 2, 2018 |
| 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: