Drug product
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
D-0357-2024
Product summary
- Firm
- Seatex LLC
- Event
- Event 93986
- Status
- Terminated
- Classification
- Class II
- Quantity
- 274 cases
- Official record key
drug-enforcement:D-0357-2024
Official wording
Reason: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Code information: Lot #: 265029, Exp. 03/27/2024; 273759, Exp. 11/29/2024.
Distribution pattern: Nationwide in the US and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations: deficiencies