FDA Inspection
BLI International, Inc.BLI International, Inc. – FDA Inspection, May 7, 2014
Record Details
This FDA Inspection record concerns BLI International, Inc., with an inspection on May 7, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BLI International, Inc.
- Inspection Date
- May 7, 2014
- Product Type
- Drugs
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ID · 4d268fb9-38de-4ad8-bac3-d80c1440e659
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 879264
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.48(b)Drains--Size, Back-siphonage Prevention
- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.170(b)Investigation of reserve sample deterioration
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
Showing 10 of 17 citations.
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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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