FDA Inspection
R.P. Kincheloe dba Perkins Healthcare TechnologiesR.P. Kincheloe dba Perkins Healthcare Technologies – FDA Inspection, Jun 29, 2010
Record Details
This FDA Inspection record concerns R.P. Kincheloe dba Perkins Healthcare Technologies, with an inspection on June 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 29, 2010
- Product Type
- Devices
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ID · e6b90817-d594-45b2-83b7-3d14441fd587
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669723
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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