# FDA 483 - Teledyne Analytical Instruments - April 25, 2023

Source: https://www.keypedia.com/records/483/teledyne-analytical-instruments/3c23df3c-5e6d-4a32-a69f-f81fee4fae47

> FDA 483 for Teledyne Analytical Instruments on April 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teledyne Analytical Instruments
- Inspection Date: 2023-04-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Teledyne Analytical Instruments, a Class II medical device manufacturer in City of Industry, CA, revealed significant deficiencies in their quality system. Observations included inadequate documentation of corrective and preventive actions, insufficient procedures for vendor qualification and auditing, and a failure to maintain complete device history records for medical oxygen sensors.

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/teledyne-analytical-instruments/441a819c-60fc-4690-b53f-ac4ff51e806d

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6