Citra Labs, LLC – FDA Inspection, Oct 30, 2009

Record Details

This FDA Inspection record concerns Citra Labs, LLC, with an inspection on October 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Citra Labs, LLC
Inspection Date: October 30, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 73173450-19e6-4fc2-9f0d-8f3d85582b30

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 626584
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 211.58Buildings not maintained in good state of repair
21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
21 CFR 211.25(a)Training , Education , Experience overall
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.46(b)Equipment for Environmental Control
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.68(a)Written calibration / inspection records not kept
21 CFR 211.84(b)Representative Samples

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