FDA Inspection
Machida Endoscope Co., Ltd.Machida Endoscope Co., Ltd. – FDA Inspection, Dec 7, 2023
Record Details
This FDA Inspection record concerns Machida Endoscope Co., Ltd., with an inspection on December 7, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a14dc926-93fb-4700-96b9-fe7e2a15087b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224275
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Machida Endoscope Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Machida Endoscope Co., Ltd.
- FDA Inspection 1030560 - 2017-08-23
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