FDA Inspection
Balassa Laboratories, Inc.Balassa Laboratories, Inc. – FDA Inspection, Feb 19, 2013
Record Details
This FDA Inspection record concerns Balassa Laboratories, Inc., with an inspection on February 19, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Balassa Laboratories, Inc.
- Inspection Date
- February 19, 2013
- Product Type
- Drugs
View Company Profile
ID · 5663f49f-622a-4e28-babb-64e4299eba72
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 819218
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.84(d)(3)Container/Closure Written Test Procedure
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully 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 |
| April 25, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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