Warning letter
ARG Laboratories, Inc.: warning letter of Jun 11, 2024
FDA warning letter 670899 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 670899 |
|---|---|
| Company | ARG Laboratories, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Issue date | Jun 11, 2024 |
| Posted date | Jul 16, 2024 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 201.128, 211.34, 201.66(b)(2), 211.22(a), 211.84(d)(1), 211.166(a), 201.66(b) |
| Inspection city | Dallas |
| Inspection ZIP | 75220 |
| Inspection start date | Sep 11, 2023 |
| 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: