Warning letter
Ranier's Compounding Laboratory: warning letter of Mar 28, 2017
FDA warning letter 521003 · Philadelphia District Office
Key facts
| Reference number | 521003 |
|---|---|
| Company | Ranier's Compounding Laboratory |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Mar 28, 2017 |
| Posted date | Jun 6, 2017 |
| Issuing office | Philadelphia District Office |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 201.115, 211.28(a), 211.42(b), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.167(a) |
| Inspection city | Jeannette |
| Inspection ZIP | 15644 |
| Inspection start date | Apr 18, 2016 |
| 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: