FDA Inspection
Gulfstream Tropical AquariumGulfstream Tropical Aquarium – FDA Inspection, Mar 9, 2009
Record Details
This FDA Inspection record concerns Gulfstream Tropical Aquarium, with an inspection on March 9, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Gulfstream Tropical Aquarium
- Inspection Date
- March 9, 2009
- Product Type
- Veterinary
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ID · a5968a30-7691-4ca2-beda-454347a710e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 568795
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 13 citations.
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Other FDA inspections of Gulfstream Tropical Aquarium
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2010 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Gulfstream Tropical Aquarium
- FDA Inspection 671629 - 2010-07-16
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