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FDA Inspection
•Bright Innovation Labs•September 16, 2015

Bright Innovation Labs – FDA Inspection, Sep 16, 2015

Record Details

This FDA Inspection record concerns Bright Innovation Labs, with an inspection on September 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Bright Innovation Labs
Inspection Date
September 16, 2015
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · eaceba94-6289-478e-9d6d-89efe41ce92c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
942919
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

4
  1. 21 CFR 211.192Quality control unit review of records
  2. 21 CFR 211.137(a)Expiration date lacking
  3. 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
  4. 21 CFR 211.180(e)(2)Items to cover on annual reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Bright Innovation Labs

2
DateClassificationOfficeProject area
October 18, 2019NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
June 7, 2018OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Bright Innovation Labs
  • FDA Inspection 1111716 - 2019-10-18
  • FDA Inspection 1054722 - 2018-06-07

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