FDA Inspection
Ken Prima Cosmeceuticals, Sdn. Bhd.Ken Prima Cosmeceuticals, Sdn. Bhd. – FDA Inspection, Sep 21, 2017
Record Details
This FDA Inspection record concerns Ken Prima Cosmeceuticals, Sdn. Bhd., with an inspection on September 21, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 52ca1ccf-4aaa-411c-bbdc-3eaaa93359cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025931
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.166(a)(4)Testing in same container - closure system
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Other FDA inspections of Ken Prima Cosmeceuticals, Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | OAI | Drug Quality Assurance | |
| July 16, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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