FDA Inspection
Heritage Hosiery IncHeritage Hosiery Inc – FDA Inspection, Jun 28, 2018
Record Details
This FDA Inspection record concerns Heritage Hosiery Inc, with an inspection on June 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Wendy R. Blame (Issuing Officer)
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ID · 6ba89b6f-fb6c-41fe-a848-13d7ab717169
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1057217
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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