Warning letter
One Way Drug LLC dba Partell Specialty Pharmacy: warning letter of Mar 13, 2019
FDA warning letter 573455 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 573455 |
|---|---|
| Company | One Way Drug LLC dba Partell Specialty Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Mar 13, 2019 |
| Posted date | Mar 26, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 201.115, 200.10(b), 211.67(a), 211.165(a), 210.1(b) |
| Inspection city | Las Vegas |
| Inspection ZIP | 89117 |
| Inspection start date | Jul 17, 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: