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FDA Inspection
•Belleview 402 LLC•April 1, 2014

Belleview 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
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 7a491ed8-03fa-40e0-b9fb-740a5ce87f0b

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
874869
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.166(b)Adequate number of batches on stability
  2. 21 CFR 211.113(a)Procedures for non-sterile drug products
  3. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Belleview 402 LLC

16
DateClassificationOfficeProject area
March 15, 2024OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 20, 2021OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 15, 2019OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 25, 2017OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 1, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 16 other inspections on the company page
Other documents for Belleview 402 LLC
  • FDA Inspection 1230040 - 2024-03-15
  • FDA Inspection 1149291 - 2021-08-20
  • FDA Inspection 1079690 - 2019-02-15
  • FDA Inspection 998830 - 2017-01-25
  • FDA Inspection 874866 - 2014-04-01

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