Warning letter
Randol Mill Pharmacy: warning letter of Sep 17, 2020
FDA warning letter 610545 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 610545 |
|---|---|
| Company | Randol Mill Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 17, 2020 |
| Posted date | Sep 29, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 201.115, 200.10(b), 211.28(a), 211.42(c), 211.42(c)(10)(v), 211.67(a), 211.113(b), 211.166(a), 210.1(b) |
| Inspection city | Arlington |
| Inspection ZIP | 76012 |
| Inspection start date | Jul 23, 2019 |
| 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: