FDA Inspection
RJL Systems, Inc.RJL Systems, Inc. – FDA Inspection, Oct 27, 2011
Record Details
This FDA Inspection record concerns RJL Systems, Inc., with an inspection on October 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- RJL Systems, Inc.
- Inspection Date
- October 27, 2011
- Product Type
- Devices
View Company Profile
ID · 008c8a3b-ebf9-484c-8477-dbbb0d870b49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751479
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of RJL Systems, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 7, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for RJL Systems, Inc.
- FDA Inspection 966108 - 2016-04-07
- FDA Inspection 860027 - 2013-12-23
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