FDA Inspection
PRIMUS GLOVES PRIVATE LTD.PRIMUS GLOVES PRIVATE LTD. – FDA Inspection, Aug 19, 2010
Record Details
This FDA Inspection record concerns PRIMUS GLOVES PRIVATE LTD., with an inspection on August 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PRIMUS GLOVES PRIVATE LTD.
- Inspection Date
- August 19, 2010
- Product Type
- Devices
View Company Profile
ID · cfe782fa-199f-4b25-a99a-be57c075c3a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679891
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(h)Use and removal, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.184DHR content
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