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FDA Inspection
•Blue Light, Inc.•April 11, 2013

Blue Light, Inc. – FDA Inspection, Apr 11, 2013

Record Details

This FDA Inspection record concerns Blue Light, Inc., with an inspection on April 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Blue Light, Inc.
Inspection Date
April 11, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · f652399a-c6e7-4b24-b1c7-3eb975dbddf4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
829555
FDA center
Human Drugs
Project area
Unapproved and Misbranded Drugs

FDA Citations

15
  1. 21 CFR 111.27(b)Instruments - calibration
  2. 21 CFR 111.80(c)Specifications - representative samples; finished batch
  3. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  4. 21 CFR 111.70(b)(1)Specifications - component identity
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.25Equipment - procedures
  7. 21 CFR 111.353Manufacturing operations - written procedures
  8. 21 CFR 111.103Written procedures - quality control operations
  9. 21 CFR 111.153Written procedures - components
  10. 21 CFR 111.553Written procedures - product complaint

Showing 10 of 15 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Blue Light, Inc.

4
DateClassificationOfficeProject area
February 14, 2023NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
August 19, 2022NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
March 13, 2019NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 29, 2016VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Blue Light, Inc.
  • FDA Inspection 1197469 - 2023-02-14
  • FDA Inspection 1180180 - 2022-08-19
  • FDA Inspection 1086598 - 2019-03-13
  • FDA Inspection 967908 - 2016-04-29

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