FDA Inspection 888701 — COSMAX, INC.
The FDA completed an inspection of COSMAX, INC. on Jul 4, 2014 in Hwaseong. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 4, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hwaseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |