FDA Inspection
Balassa Laboratories, Inc.Balassa Laboratories, Inc. – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Balassa Laboratories, Inc., with an inspection on August 21, 2026, issued by the Florida District Office, covering foods & cosmetics.
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ID · a80d2983-3380-47c8-ad3e-e7ef4d53d37f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1332070
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 108.25(c)(2)Process filing
- 21 CFR 108.25(f)Approved school
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.113(b)(2)Quality control - reject; specification not met
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.255(c)Batch record - each step
- 21 CFR 111.70(e)Specifications - finished dietary supplement
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Other FDA inspections of Balassa Laboratories, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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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