FDA Inspection
Aristotech Industries GmbHAristotech Industries GmbH – FDA Inspection, Aug 30, 2018
Record Details
This FDA Inspection record concerns Aristotech Industries GmbH, with an inspection on August 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7d65e121-77c4-4263-99e7-615f2347a83f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064236
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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