FDA Inspection
Belleview 402 LLCBelleview 402 LLC – FDA Inspection, Apr 1, 2014
Record Details
This FDA Inspection record concerns Belleview 402 LLC, with an inspection on April 1, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Belleview 402 LLC
- Inspection Date
- April 1, 2014
- Product Type
- Drugs
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ID · a7e7ab17-90b5-4ead-b09f-aa5a264a2012
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 874866
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.204Returned drug procedures in writing and 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 |
| 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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