FDA Inspection
Acra Cut, Inc.Acra Cut, Inc. – FDA Inspection, Oct 16, 2017
Record Details
This FDA Inspection record concerns Acra Cut, Inc., with an inspection on October 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · aacf8839-daea-4386-9dcc-23cd8b0c8d4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028712
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.50(b)(2)Providing Incomplete or Missing Information
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Other FDA inspections of Acra Cut, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2018 | Not classified | New England District Office | |
| December 14, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 22, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Acra Cut, Inc.
- FDA Inspection 1107690 - 2018-10-31
- FDA Inspection 811158 - 2012-12-14
- FDA Inspection 696134 - 2010-10-22
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