FDA Inspection
Agropharma Laboratories Inc.Agropharma Laboratories Inc. – FDA Inspection, Aug 19, 2009
Record Details
This FDA Inspection record concerns Agropharma Laboratories Inc., with an inspection on August 19, 2009, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Agropharma Laboratories Inc.
- Inspection Date
- August 19, 2009
- Product Type
- Veterinary
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ID · bcaed8b6-260f-4593-91ba-dd575e629f98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596471
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
23- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(5)Testing Calculations
Showing 10 of 23 citations.
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Other FDA inspections of Agropharma Laboratories Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 12, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 20, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 19, 2011 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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