FDA Inspection
Special Products IncSpecial Products Inc – FDA Inspection, Aug 20, 2014
Record Details
This FDA Inspection record concerns Special Products Inc, with an inspection on August 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Special Products Inc
- Inspection Date
- August 20, 2014
- Product Type
- Devices
View Company Profile
ID · 83c6006d-b7cf-4c76-b532-60e2dd81afbf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891907
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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