FDA Inspection
Lady BusinessLady Business – FDA Inspection, Aug 28, 2019
Record Details
This FDA Inspection record concerns Lady Business, with an inspection on August 28, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8252233f-ca4d-42e2-ae42-17f24bdfdc58
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1100817
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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