FDA Inspection
Aesku Systems GmbH & Co. KGAesku Systems GmbH & Co. KG – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns Aesku Systems GmbH & Co. KG, with an inspection on April 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cfa75762-b4fc-4e52-afb2-614fc1964766
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051217
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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