FDA Inspection
Greatbatch LtdGreatbatch Ltd – FDA Inspection, Aug 21, 2012
Record Details
This FDA Inspection record concerns Greatbatch Ltd, with an inspection on August 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Greatbatch Ltd
- Inspection Date
- August 21, 2012
- Product Type
- Devices
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ID · ddc98ec9-8c2a-4bc2-986a-eacf5135fc91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795448
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(e)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Greatbatch Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 13, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Greatbatch Ltd
- FDA Inspection 1008017 - 2017-03-23
- FDA Inspection 879257 - 2014-05-16
- FDA Inspection 638223 - 2010-01-13
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