FDA Inspection
Yates Motloid CoYates Motloid Co – FDA Inspection, May 13, 2009
Record Details
This FDA Inspection record concerns Yates Motloid Co, with an inspection on May 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Yates Motloid Co
- Inspection Date
- May 13, 2009
- Product Type
- Devices
View Company Profile
ID · 4544b43d-efa3-4547-b71f-812f1bb009cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 582130
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)(2)Production monitoring and control
- 21 CFR 820.100(a)(7)Management review of CAPA
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Yates Motloid Co
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2024 | NAI | Chicago District Office | Postmarket Assurance: Medical Devices |
| February 8, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 27, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 30, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Yates Motloid Co
- FDA Inspection 1252450 - 2024-10-24
- FDA Inspection 1082637 - 2019-02-08
- FDA Inspection 977043 - 2015-10-27
- FDA Inspection 845468 - 2013-08-30
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.