FDA Inspection
PatCen Healthcare Inc.PatCen Healthcare Inc. – FDA Inspection, Jan 14, 2020
Record Details
This FDA Inspection record concerns PatCen Healthcare Inc., with an inspection on January 14, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PatCen Healthcare Inc.
- Inspection Date
- January 14, 2020
- Product Type
- Devices
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ID · 809a619c-539b-49c3-b73f-2160eeac2d80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115031
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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