FDA Inspection
Mack Prototype Inc.Mack Prototype Inc. – FDA Inspection, Oct 8, 2015
Record Details
This FDA Inspection record concerns Mack Prototype Inc., with an inspection on October 8, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mack Prototype Inc.
- Inspection Date
- October 8, 2015
- Product Type
- Devices
View Company Profile
ID · 03137022-2b2e-4ca1-a09a-7b442fc49584
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947599
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.70(a)Production processes
- 21 CFR 820.86Acceptance status
Full citation text and observation details available on the Dashboard.
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.