FDA Inspection
Oh So Clean, Inc. dba CleanWell CompanyOh So Clean, Inc. dba CleanWell Company – FDA Inspection, Aug 30, 2010
Record Details
This FDA Inspection record concerns Oh So Clean, Inc. dba CleanWell Company, with an inspection on August 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 30, 2010
- Product Type
- Drugs
View Company Profile
ID · 7a9e42a4-524e-4103-af90-3cfd202e3e17
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 675728
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Oh So Clean, Inc. dba CleanWell Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Oh So Clean, Inc. dba CleanWell Company
- FDA Inspection 782419 - 2012-05-18
- FDA Inspection 603349 - 2009-08-03
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