FDA Inspection
Medipack Medical Packaging Mfg CoMedipack Medical Packaging Mfg Co – FDA Inspection, Jul 21, 2016
Record Details
This FDA Inspection record concerns Medipack Medical Packaging Mfg Co, with an inspection on July 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 21, 2016
- Product Type
- Devices
View Company Profile
ID · 0ae0f99a-be9a-4ea9-89c9-3645c0c64d54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983539
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medipack Medical Packaging Mfg Co
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2024 | Not classified | Office of Inspections and Investigations |
Other documents for Medipack Medical Packaging Mfg Co
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.