FDA Inspection
TJN Mfg IncTJN Mfg Inc – FDA Inspection, Jun 6, 2019
Record Details
This FDA Inspection record concerns TJN Mfg Inc, with an inspection on June 6, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 842dec68-3452-4d71-a052-74f6f13f23ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092183
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of TJN Mfg Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2024 | Not classified | Kansas City District Office | Compliance: Devices |
| April 12, 2018 | Not classified | Kansas City District Office | |
| December 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TJN Mfg Inc
- FDA Inspection 1235911 - 2024-04-11
- FDA Inspection 1048936 - 2018-04-12
- FDA Inspection 809807 - 2012-12-07
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