FDA Inspection
Johns Hopkins University LaboratoryJohns Hopkins University Laboratory – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns Johns Hopkins University Laboratory, with an inspection on June 14, 2019, issued by the Baltimore District Office, covering medical devices & rad health.
- Inspection Date
- June 14, 2019
- Product Type
- Medical Devices & Rad Health
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ID · 6f2ccf3e-46bc-4c9b-b459-c05372b57ec0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093059
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 58.107Test article: handling
- 21 CFR 58.185(a)(9)Final report: circumstances affecting data qual., integrity
- 21 CFR 58.33(e)Study director: follow GLP regulations
- 21 CFR 58.81(b)SOPs: required
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