FDA Inspection
Ivers-Lee AGIvers-Lee AG – FDA Inspection, Jul 5, 2019
Record Details
This FDA Inspection record concerns Ivers-Lee AG, with an inspection on July 5, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 18d20e1a-6d40-45a9-931c-8038c840501d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095767
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Sampling/testing of drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
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Other FDA inspections of Ivers-Lee AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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