FDA Inspection
Richardson Products Inc.Richardson Products Inc. – FDA Inspection, Aug 27, 2026
Record Details
This FDA Inspection record concerns Richardson Products Inc., with an inspection on August 27, 2026, issued by the Chicago District Office, covering medical devices & rad health.
- Company
- Richardson Products Inc.
- Inspection Date
- August 27, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 6524fc3b-68bb-476d-8d11-8b676bd275c7
Inspection Facts
- Inspection number
- 1333198
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 6.2Personnel competency not adequate
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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