FDA Inspection
Balassa Laboratories, Inc.Balassa Laboratories, Inc. – FDA Inspection, Apr 25, 2014
Record Details
This FDA Inspection record concerns Balassa Laboratories, Inc., with an inspection on April 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Balassa Laboratories, Inc.
- Inspection Date
- April 25, 2014
- Product Type
- Drugs
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ID · 8d04f8e4-4298-47e2-b160-b3801318c9a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 876075
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Balassa Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2026 | VAI | Florida District Office | Foodborne Biological Hazards |
| April 7, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 19, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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