FDA Inspection
Pharmaceutical Innovations, Inc.Pharmaceutical Innovations, Inc. – FDA Inspection, Jun 19, 2017
Record Details
This FDA Inspection record concerns Pharmaceutical Innovations, Inc., with an inspection on June 19, 2017, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- June 19, 2017
- Product Type
- Medical Devices & Rad Health
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ID · 5ddf502c-d80a-4d61-9aa2-0a9a4452cfbe
Inspection Facts
- Inspection number
- 1014902
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Showing 10 of 13 citations.
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Other FDA inspections of Pharmaceutical Innovations, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 29, 2019 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 3, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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