FDA Inspection
Allergan Pharmaceuticals IrelandAllergan Pharmaceuticals Ireland – FDA Inspection, Jul 3, 2015
Record Details
This FDA Inspection record concerns Allergan Pharmaceuticals Ireland, with an inspection on July 3, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 3, 2015
- Product Type
- Devices
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ID · 7d69a031-24c4-4f49-b2ff-c3775b5b0ae8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Allergan Pharmaceuticals Ireland
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2025 | Not classified | Office of Inspections and Investigations | |
| June 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Allergan Pharmaceuticals Ireland
- FDA Inspection 1259046 - 2025-01-30
- FDA Inspection 1194596 - 2022-06-17
- FDA Inspection 1117366 - 2018-05-04
- FDA Inspection 1002463 - 2016-12-16
- FDA Inspection 842267 - 2013-07-11
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