FDA Inspection 873495 — Turnco Tool & Instrument, Inc.

Turnco Tool & Instrument, Inc. — FEI 3009241418

The FDA completed an inspection of Turnco Tool & Instrument, Inc. on March 28, 2014 in Georgetown, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 28, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Georgetown, TX (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
320121 CFR 820.40(a)Not approved or obsolete document retrieval
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.