FDA Inspection
Myerson LLCMyerson LLC – FDA Inspection, May 16, 2017
Record Details
This FDA Inspection record concerns Myerson LLC, with an inspection on May 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 46bfe119-bfee-41dd-956b-e32383fbdac9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1012095
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 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(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(j)Design history file
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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 |
| September 28, 2018 | VAI | 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 1067061 - 2018-09-28
- FDA Inspection 881660 - 2014-06-06
- FDA Inspection 654358 - 2010-03-19
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