FDA Inspection
Asteelflash Design Solutions Hamburg GmbHAsteelflash Design Solutions Hamburg GmbH – FDA Inspection, May 9, 2019
Record Details
This FDA Inspection record concerns Asteelflash Design Solutions Hamburg GmbH, with an inspection on May 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cb20766f-b513-43cf-a9c3-ff8739df7d29
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090087
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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