FDA Inspection
Ralston GroupRalston Group – FDA Inspection, Mar 7, 2019
Record Details
This FDA Inspection record concerns Ralston Group, with an inspection on March 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Wendy R. Blame (Issuing Officer)
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ID · 3e0a1bfe-49ca-4b0e-8946-b4b46b4aaaef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081709
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.70(g)(2)Periodic equipment inspections
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Ralston Group
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ralston Group
- FDA Inspection 920348 - 2015-04-02
- FDA Inspection 864962 - 2014-02-06
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