FDA Inspection
Celletech, LtdCelletech, Ltd – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Celletech, Ltd, with an inspection on February 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fd704e4d-0629-4ce5-8788-e7bec146a1d8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001136
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Celletech, Ltd
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 16, 2021 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 29, 2021 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 13, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Celletech, Ltd
- FDA Inspection 1202413 - 2023-04-05
- FDA Inspection 1159946 - 2021-12-16
- FDA Inspection 1140987 - 2021-04-29
- FDA Inspection 1081585 - 2019-02-13
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