FDA Inspection
Everything Bags IncEverything Bags Inc – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Everything Bags Inc, with an inspection on June 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Joseph D. Gong (Company Rep)
- Marissa S. Steinhagen (Issuing Officer)
View Company Profile
ID · dc63a604-ea39-45d9-9c5a-4fc71a3cbd07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014472
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 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
- 21 CFR 803.17Lack of Written MDR Procedures
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