FDA Inspection
Hilsinger Company Parent, LLCHilsinger Company Parent, LLC – FDA Inspection, Aug 14, 2017
Record Details
This FDA Inspection record concerns Hilsinger Company Parent, LLC, with an inspection on August 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 204f1623-0cbf-4155-8f98-6a7e1adbe23c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021686
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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