FDA Inspection 937673 — JO Cosmetics Co., Ltd.
The FDA completed an inspection of JO Cosmetics Co., Ltd. on June 12, 2015 in Hanyu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 12, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hanyu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |