FDA Inspection
Parker Medical Systems Division MerillvilleParker Medical Systems Division Merillville – FDA Inspection, May 20, 2019
Record Details
This FDA Inspection record concerns Parker Medical Systems Division Merillville, with an inspection on May 20, 2019, issued by the Detroit District Office, covering medical devices & rad health.
- Inspection Date
- May 20, 2019
- Product Type
- Medical Devices & Rad Health
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ID · cd1c842d-d984-44f5-b996-f2d5d890ccb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090202
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Parker Medical Systems Division Merillville
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 19, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Parker Medical Systems Division Merillville
- FDA Inspection 897907 - 2014-08-07
- FDA Inspection 573525 - 2009-03-19
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