FDA Inspection 889623 — Ken Prima Cosmeceuticals, Sdn. Bhd.
The FDA completed an inspection of Ken Prima Cosmeceuticals, Sdn. Bhd. on July 16, 2014 in Perai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 16, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Perai (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |