FDA Inspection
Angelini Pharma, Inc.Angelini Pharma, Inc. – FDA Inspection, Sep 2, 2016
Record Details
This FDA Inspection record concerns Angelini Pharma, Inc., with an inspection on September 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Angelini Pharma, Inc.
- Inspection Date
- September 2, 2016
- Product Type
- Devices
View Company Profile
ID · 88448e94-8938-427f-8816-35d8c4693202
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 989300
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Angelini Pharma, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 17, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 19, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Angelini Pharma, Inc.
- FDA Inspection 920215 - 2015-03-17
- FDA Inspection 875272 - 2014-04-22
- FDA Inspection 740481 - 2011-08-19
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