FDA Inspection
Precision Needle Manufacturing, Inc.Precision Needle Manufacturing, Inc. – FDA Inspection, Jan 9, 2014
Record Details
This FDA Inspection record concerns Precision Needle Manufacturing, Inc., with an inspection on January 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 9, 2014
- Product Type
- Devices
View Company Profile
ID · 76d0ae5f-4b19-499a-918b-3ca489f379ce
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 864830
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
- 21 CFR 820.50(a)(2)Supplier oversight
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