Drug product
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
D-0358-2024
Product summary
- Firm
- Seatex LLC
- Event
- Event 93986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 cases
- Official record key
drug-enforcement:D-0358-2024
Official wording
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Code information: Lot #: 251176, Exp. 06/23/2024.
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: deficiencies