FDA Inspection
Balassa Laboratories, Inc.Balassa Laboratories, Inc. – FDA Inspection, Apr 7, 2023
Record Details
This FDA Inspection record concerns Balassa Laboratories, Inc., with an inspection on April 7, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 35115857-0fca-43da-b19b-60881ad12acc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1202446
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
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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 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 25, 2014 | 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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