FDA Inspection
The Original Cream CompanyThe Original Cream Company – FDA Inspection, May 14, 2013
Record Details
This FDA Inspection record concerns The Original Cream Company, with an inspection on May 14, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- The Original Cream Company
- Inspection Date
- May 14, 2013
- Product Type
- Drugs
View Company Profile
ID · cd5be227-8eef-44a7-9665-b52dca230590
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 831650
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
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