FDA Inspection
PLAYGRO USA LLCPLAYGRO USA LLC – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns PLAYGRO USA LLC, with an inspection on June 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · afdcaefd-44e8-425b-9c13-485e6ba4660b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093298
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.198(g)Foreign complaint files
- 21 CFR 803.17Lack of Written MDR Procedures
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