FDA Inspection
Balassa Laboratories, Inc.Balassa Laboratories, Inc. – FDA Inspection, Apr 23, 2018
Record Details
This FDA Inspection record concerns Balassa Laboratories, Inc., with an inspection on April 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3819eae3-63ea-4caf-9306-2da8f58006f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049200
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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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 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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