FDA Inspection 1120204 — S&S X-Ray Products, Inc.

S&S X-Ray Products, Inc. — FEI 1650045

The FDA completed an inspection of S&S X-Ray Products, Inc. on March 9, 2020 in Houston, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 9, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Houston, TX (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
320621 CFR 820.50(b)Approval, inadequate purchasing data