FDA Inspection
PC Marketing, Inc.PC Marketing, Inc. – FDA Inspection, Jan 19, 2017
Record Details
This FDA Inspection record concerns PC Marketing, Inc., with an inspection on January 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a5512488-9254-46c4-8e75-6edd86d065b9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1003901
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.40(b)Report of malfunction likely to cause death or injury
- 21 CFR 820.198(g)Foreign complaint files
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 1040.20(e)(1)(i)Reproduction of labels
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of PC Marketing, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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