FDA Inspection
Bay Shore Medical Equipment, LLCBay Shore Medical Equipment, LLC – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns Bay Shore Medical Equipment, LLC, with an inspection on April 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 73bf69ed-f9d9-424c-a2ed-022139e2451c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087172
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Bay Shore Medical Equipment, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2023 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bay Shore Medical Equipment, LLC
- FDA Inspection 1206835 - 2023-05-02
- FDA Inspection 818070 - 2013-01-29
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