FDA Inspection
Ken Prima Cosmeceuticals, Sdn. Bhd.Ken Prima Cosmeceuticals, Sdn. Bhd. – FDA Inspection, Jul 16, 2014
Record Details
This FDA Inspection record concerns Ken Prima Cosmeceuticals, Sdn. Bhd., with an inspection on July 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 16, 2014
- Product Type
- Drugs
View Company Profile
ID · b38317e4-68fe-4d5d-860d-1eb9bd3ee027
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 889623
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ken Prima Cosmeceuticals, Sdn. Bhd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | OAI | Drug Quality Assurance | |
| September 21, 2017 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
Other documents for Ken Prima Cosmeceuticals, Sdn. Bhd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.