FDA Inspection 954584 — P&G K.K.
The FDA completed an inspection of P&G K.K. on Dec 11, 2015 in Yasu. 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
- Dec 11, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yasu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |