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FDA Inspection
•Oh So Clean, Inc. dba CleanWell Company•May 18, 2012

Oh So Clean, Inc. dba CleanWell Company – FDA Inspection, May 18, 2012

Record Details

This FDA Inspection record concerns Oh So Clean, Inc. dba CleanWell Company, with an inspection on May 18, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Oh So Clean, Inc. dba CleanWell Company
Inspection Date
May 18, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · ad2c3595-3659-42e2-b788-618c6d38e0af

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
782419
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
  2. 21 CFR 211.100(a)Absence of Written Procedures
  3. 21 CFR 211.166(a)(4)Testing in same container - closure system

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Oh So Clean, Inc. dba CleanWell Company

2
DateClassificationOfficeProject area
August 30, 2010OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 3, 2009NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Oh So Clean, Inc. dba CleanWell Company
  • FDA Inspection 675728 - 2010-08-30
  • FDA Inspection 603349 - 2009-08-03

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