FDA Inspection
Greenwald Surgical Company, Inc.Greenwald Surgical Company, Inc. – FDA Inspection, Mar 15, 2018
Record Details
This FDA Inspection record concerns Greenwald Surgical Company, Inc., with an inspection on March 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e4b74e44-c482-4a12-bde1-b52e55abaf93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044946
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Greenwald Surgical Company, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 27, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 20, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Greenwald Surgical Company, Inc.
- FDA Inspection 898361 - 2014-09-17
- FDA Inspection 800967 - 2012-09-27
- FDA Inspection 745573 - 2011-09-20
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