FDA Inspection
AMPHENOL ALDEN PRODUCTSAMPHENOL ALDEN PRODUCTS – FDA Inspection, Oct 25, 2018
Record Details
This FDA Inspection record concerns AMPHENOL ALDEN PRODUCTS, with an inspection on October 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a2a62272-096a-4fd2-bfd8-55556052920f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074704
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of AMPHENOL ALDEN PRODUCTS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2024 | Not classified | Office of Inspections and Investigations |
Other documents for AMPHENOL ALDEN PRODUCTS
- FDA Inspection 1227776 - 2024-01-12
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