FDA Inspection
Belleview 402 LLCBelleview 402 LLC – FDA Inspection, Aug 20, 2021
Record Details
This FDA Inspection record concerns Belleview 402 LLC, with an inspection on August 20, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Belleview 402 LLC
- Inspection Date
- August 20, 2021
- Product Type
- Drugs
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ID · b2b4fcdf-15ff-446e-8d0f-cfdbe2333dfd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1149291
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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 |
| April 1, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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