FDA Inspection
Highland Industries,Inc.Highland Industries,Inc. – FDA Inspection, Jul 25, 2019
Record Details
This FDA Inspection record concerns Highland Industries,Inc., with an inspection on July 25, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c69cf038-edf1-45d8-b291-81d8c69f7257
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1097421
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.184DHR content
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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