FDA Inspection 890008 — Jaychem Industries Ltd
The FDA completed an inspection of Jaychem Industries Ltd on Jul 10, 2014 in Auckland. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 10, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Auckland (New Zealand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |