FDA Inspection 1099164 — Ernest Jackson & Co., Ltd.
The FDA completed an inspection of Ernest Jackson & Co., Ltd. on August 8, 2019 in Crediton. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 8, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Crediton (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |