FDA Inspection
Ashaway Line & Twine Mfg. Co.Ashaway Line & Twine Mfg. Co. – FDA Inspection, Nov 12, 2013
Record Details
This FDA Inspection record concerns Ashaway Line & Twine Mfg. Co., with an inspection on November 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 12, 2013
- Product Type
- Devices
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ID · 8e189340-95d7-4446-8ed5-45481146eed3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856412
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Ashaway Line & Twine Mfg. Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 28, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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