FDA Inspection
Clientele, Inc.Clientele, Inc. – FDA Inspection, Feb 7, 2020
Record Details
This FDA Inspection record concerns Clientele, Inc., with an inspection on February 7, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Clientele, Inc.
- Inspection Date
- February 7, 2020
- Product Type
- Drugs
View Company Profile
ID · e02ad1d6-0d83-44d2-9eab-25f6d088f0f9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1117868
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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