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FDA Inspection
•Obagi Medical Products•December 9, 2010

Obagi Medical Products – FDA Inspection, Dec 9, 2010

Record Details

This FDA Inspection record concerns Obagi Medical Products, with an inspection on December 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Obagi Medical Products
Inspection Date
December 9, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4ca72467-119f-431b-8923-8929003ef3d5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
701364
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.137(b)Storage conditions
  2. 21 CFR 211.67(c)Cleaning/maintenance records not kept
  3. 21 CFR 211.166(a)(4)Testing in same container - closure system
  4. 21 CFR 211.180(e)(1)Review of representative number of batches
  5. 21 CFR 211.192Written record of investigation incomplete

Full citation text and observation details available on the Dashboard.

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