FDA Inspection
Parker Medical Systems Division MerillvilleParker Medical Systems Division Merillville – FDA Inspection, Aug 7, 2014
Record Details
This FDA Inspection record concerns Parker Medical Systems Division Merillville, with an inspection on August 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 7, 2014
- Product Type
- Devices
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ID · e5c9f9c3-1542-48b2-92d7-e2afbdc15fd4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897907
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Parker Medical Systems Division Merillville
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2019 | VAI | Detroit District Office | Project Evaluation: Devices |
| March 19, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Parker Medical Systems Division Merillville
- FDA Inspection 1090202 - 2019-05-20
- FDA Inspection 573525 - 2009-03-19
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