FDA Inspection 907253 — Miers Laboratories Ltd.
The FDA completed an inspection of Miers Laboratories Ltd. on Nov 20, 2014 in Lower Hutt. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 20, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lower Hutt (New Zealand)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |