FDA Inspection
S&S X-Ray Products, Inc.S&S X-Ray Products, Inc. – FDA Inspection, Mar 28, 2019
Record Details
This FDA Inspection record concerns S&S X-Ray Products, Inc., with an inspection on March 28, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0150d913-5b89-4f8c-aa64-ade9db4aedae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1084223
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Showing 10 of 13 citations.
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Other FDA inspections of S&S X-Ray Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 23, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for S&S X-Ray Products, Inc.
- FDA Inspection 1120204 - 2020-03-09
- FDA Inspection 714144 - 2011-03-23
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