FDA Inspection
Agropharma Laboratories Inc.Agropharma Laboratories Inc. – FDA Inspection, May 7, 2010
Record Details
This FDA Inspection record concerns Agropharma Laboratories Inc., with an inspection on May 7, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Agropharma Laboratories Inc.
- Inspection Date
- May 7, 2010
- Product Type
- Drugs
View Company Profile
ID · 063ec35e-5c19-4069-9903-85fc9e94ec9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 653633
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 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 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 13 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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