FDA Inspection 1017865 — JO Cosmetics Co., Ltd.
The FDA completed an inspection of JO Cosmetics Co., Ltd. on Jul 14, 2017 in Ota. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 14, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ota (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3577 | 21 CFR 211.101(b)(4) | Subdivided component/container/finished drug |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |