Warning letter
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding: warning letter of Nov 18, 2022
FDA warning letter 642792 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 642792 |
|---|---|
| Company | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Nov 18, 2022 |
| Posted date | Jan 24, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| Inspection city | Richardson |
| Inspection ZIP | 75081 |
| Inspection start date | Mar 1, 2022 |
| 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: