FDA Inspection
Myerson LLCMyerson LLC – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns Myerson LLC, with an inspection on September 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fa306510-2edc-4593-9d37-a3127e8e7334
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067061
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Myerson LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Myerson LLC
- FDA Inspection 1141205 - 2021-05-04
- FDA Inspection 1012095 - 2017-05-16
- FDA Inspection 881660 - 2014-06-06
- FDA Inspection 654358 - 2010-03-19
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