Belmora LLC — FDA Facility Profile
Belmora LLC is an FDA-inspected facility (FEI 3009442527) located in Arlington, VA, US. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 13, 2017: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Jun 8, 2017
- Recalls as the recalling firm
- 1, latest Dec 18, 2012
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 13, 2017 | Voluntary Action Indicated (VAI) | Failure to develop written procedures (21 CFR 314.80(b)) Interval (21 CFR 314.80(c)(2)) Timely submission (21 CFR 314.81(b)(2)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Dec 18, 2012 | Class III | D-136-2013 | Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200… Defective Container: Product lacks tamper evident breakaway band on cap. |
Facility details
- Company
- Belmora LLC
- Location
- Arlington, VA (US)
- Source
- inspections