FDA Inspection
Angelini Pharma Inc.Angelini Pharma Inc. – FDA Inspection, Apr 1, 2019
Record Details
This FDA Inspection record concerns Angelini Pharma Inc., with an inspection on April 1, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Dawn M. Braswell (Investigator)
- Joshua J. Silvestri
- Lisa A. Stura (Issuing Officer)
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ID · 3cf27ff7-d865-4d54-a08a-97611a803783
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084949
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Angelini Pharma Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Angelini Pharma Inc.
- FDA Inspection 1196579 - 2022-12-06
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