FDA Inspection
Precise Plastics, Inc.Precise Plastics, Inc. – FDA Inspection, Apr 28, 2016
Record Details
This FDA Inspection record concerns Precise Plastics, Inc., with an inspection on April 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Precise Plastics, Inc.
- Inspection Date
- April 28, 2016
- Product Type
- Devices
View Company Profile
ID · a7b8eb3e-14f3-43c8-a0c1-20825a1301a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972657
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Precise Plastics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 5, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Precise Plastics, Inc.
- FDA Inspection 1020408 - 2017-07-12
- FDA Inspection 791827 - 2012-07-19
- FDA Inspection 556480 - 2009-01-05
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.