FDA Inspection
BLI International, Inc.BLI International, Inc. – FDA Inspection, May 16, 2013
Record Details
This FDA Inspection record concerns BLI International, Inc., with an inspection on May 16, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BLI International, Inc.
- Inspection Date
- May 16, 2013
- Product Type
- Drugs
View Company Profile
ID · 641bb538-7887-418d-8553-8c89ee1f5721
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832048
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.122(d)Labels and labeling stored separately
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 12 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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