FDA Inspection 1096046 — RMG ART Laboratories, LLC
The FDA completed an inspection of RMG ART Laboratories, LLC on July 12, 2019 in Temple Terrace, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Temple Terrace, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |