FDA Inspection
ANI-KAL II, LLCANI-KAL II, LLC – FDA Inspection, Nov 14, 2008
Record Details
This FDA Inspection record concerns ANI-KAL II, LLC, with an inspection on November 14, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ANI-KAL II, LLC
- Inspection Date
- November 14, 2008
- Product Type
- Devices
View Company Profile
ID · 8f46baa0-2332-4788-85bc-ae684facfe73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 546689
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.198(a)General
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
- 21 CFR 820.100(b)Procedures
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