FDA Inspection
Laser Pharmaceuticals LLCLaser Pharmaceuticals LLC – FDA Inspection, Dec 16, 2016
Record Details
This FDA Inspection record concerns Laser Pharmaceuticals LLC, with an inspection on December 16, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · af3bf536-8e8d-468d-8ece-dd427b7946e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009414
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 111.105(b)Quality control - supplier qualification
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Other FDA inspections of Laser Pharmaceuticals LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2012 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| January 6, 2012 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Laser Pharmaceuticals LLC
- FDA Inspection 799021 - 2012-04-10
- FDA Inspection 762796 - 2012-01-06
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