FDA Inspection
Ashaway Line & Twine Mfg. Co.Ashaway Line & Twine Mfg. Co. – FDA Inspection, May 6, 2011
Record Details
This FDA Inspection record concerns Ashaway Line & Twine Mfg. Co., with an inspection on May 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 6, 2011
- Product Type
- Devices
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ID · 895ed897-2b10-48b3-b814-a0cd534db19d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 724630
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.70(a)Production processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Ashaway Line & Twine Mfg. Co.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2013 | 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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