FDA Inspection
Belleview 402 LLCBelleview 402 LLC – FDA Inspection, Nov 24, 2010
Record Details
This FDA Inspection record concerns Belleview 402 LLC, with an inspection on November 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Belleview 402 LLC
- Inspection Date
- November 24, 2010
- Product Type
- Drugs
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ID · 6e09987f-1faa-429a-9ecd-f283e6cafa4a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 702487
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Belleview 402 LLC
16| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 20, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 1, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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