FDA Inspection
MAXSTAR INDUSTRIAL CO LTDMAXSTAR INDUSTRIAL CO LTD – FDA Inspection, Feb 9, 2023
Record Details
This FDA Inspection record concerns MAXSTAR INDUSTRIAL CO LTD, with an inspection on February 9, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 562706bc-5798-43c3-a770-5eb53ea0bace
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196823
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.80(b)Incoming acceptance records, documentation
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Other FDA inspections of MAXSTAR INDUSTRIAL CO LTD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2026 | Not classified | Office of Inspections and Investigations | |
| October 19, 2017 | Not classified | Office of Inspections and Investigations |
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