FDA Inspection
Life Technologies CorporationLife Technologies Corporation – FDA Inspection, Sep 5, 2013
Record Details
This FDA Inspection record concerns Life Technologies Corporation, with an inspection on September 5, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 5, 2013
- Product Type
- Devices
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ID · b1c0b7dd-4417-449e-a69c-9c41b09ecf19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847614
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 806.10(c)(11)Domestic & foreign consignees
- 21 CFR 806.10(c)(9)Device number, identification
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Other FDA inspections of Life Technologies Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Life Technologies Corporation
- FDA Inspection 911101 - 2015-01-20
- FDA Inspection 744551 - 2011-09-14
- FDA Inspection 548712 - 2008-12-11
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