Warning letter
Malanda, Inc. dba Mandell's Clinical Pharmacy: warning letter of Jun 9, 2020
FDA warning letter 608320 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 608320 |
|---|---|
| Company | Malanda, Inc. dba Mandell's Clinical Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Jun 9, 2020 |
| Posted date | Jun 30, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| Inspection city | Somerset |
| Inspection ZIP | 08873 |
| Inspection start date | Jun 17, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: