FDA Inspection
BLI International, Inc.BLI International, Inc. – FDA Inspection, Jun 2, 2015
Record Details
This FDA Inspection record concerns BLI International, Inc., with an inspection on June 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BLI International, Inc.
- Inspection Date
- June 2, 2015
- Product Type
- Drugs
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ID · 9545ea2c-9b03-4c95-95ef-006f7b1f5f57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927833
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.42(c)(4)In-Process Material Area
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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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 |
| 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 992510 - 2016-11-02
- FDA Inspection 879264 - 2014-05-07
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