FDA Inspection
Dermatreate, LLCDermatreate, LLC – FDA Inspection, Mar 14, 2012
Record Details
This FDA Inspection record concerns Dermatreate, LLC, with an inspection on March 14, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dermatreate, LLC
- Inspection Date
- March 14, 2012
- Product Type
- Drugs
View Company Profile
ID · d45dadf8-4646-42ca-95e3-60c6ae3be228
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 773835
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
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