FDA Inspection
Laser Pharmaceuticals LLCLaser Pharmaceuticals LLC – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns Laser Pharmaceuticals LLC, with an inspection on June 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Lillie D. Witcher (Company Rep)
- Rachael L. Derby (Issuing Officer)
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ID · 952ec322-8034-4683-9a2b-e79c7fed97c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1012368
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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