FDA Inspection
Ken Prima Cosmeceuticals, Sdn. Bhd.Ken Prima Cosmeceuticals, Sdn. Bhd. – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Ken Prima Cosmeceuticals, Sdn. Bhd., with an inspection on November 17, 2023, covering drugs.
- Inspection Date
- November 17, 2023
- Product Type
- Drugs
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ID · 54f11c3b-d308-417f-855a-83b004e53ae7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1223306
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(1)Component identity verification
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Other FDA inspections of Ken Prima Cosmeceuticals, Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2017 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| July 16, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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