FDA Inspection
Teledyne Analytical InstrumentsTeledyne Analytical Instruments – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns Teledyne Analytical Instruments, with an inspection on June 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3a96c64-a851-43b8-ac1d-8eeafa2096d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016446
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.198(a)Complaints
- 21 CFR 806.10(c)(8)Illness report
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Teledyne Analytical Instruments
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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