FDA Inspection
BLI International, Inc.BLI International, Inc. – FDA Inspection, May 13, 2011
Record Details
This FDA Inspection record concerns BLI International, Inc., with an inspection on May 13, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BLI International, Inc.
- Inspection Date
- May 13, 2011
- Product Type
- Drugs
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ID · bb8b577e-1927-4ee0-90e3-6aa185144b3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728240
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of BLI International, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2025 | Not classified | New York District Office | |
| April 24, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 2, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BLI International, Inc.
- FDA Inspection 1268782 - 2025-04-11
- FDA Inspection 1234201 - 2024-04-24
- FDA Inspection 1095698 - 2019-06-13
- FDA Inspection 992510 - 2016-11-02
- FDA Inspection 927833 - 2015-06-02
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