FDA Inspection
BLI International, Inc.BLI International, Inc. – FDA Inspection, Nov 2, 2016
Record Details
This FDA Inspection record concerns BLI International, Inc., with an inspection on November 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 99148fbb-82e3-471e-80af-3b38b1002962
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992510
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.50Sewage and refuse disposal in safe manner
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 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 |
| June 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 7, 2014 | 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 927833 - 2015-06-02
- FDA Inspection 879264 - 2014-05-07
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