FDA Inspection
TJN Mfg IncTJN Mfg Inc – FDA Inspection, Apr 11, 2024
Record Details
This FDA Inspection record concerns TJN Mfg Inc, with an inspection on April 11, 2024, issued by the Kansas City District Office, covering medical devices & rad health.
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ID · 7735238e-b989-45df-bbd0-06ac4c0eb1b0
Inspection Facts
- Inspection number
- 1235911
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of TJN Mfg Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1092183 - 2019-06-06
- FDA Inspection 1048936 - 2018-04-12
- FDA Inspection 809807 - 2012-12-07
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