# FDA 483 - King Systems Corp. dba Ambu, Inc. - April 15, 2021

Source: https://www.keypedia.com/records/483/king-systems-corp-dba-ambu-inc/3f620c99-807d-42fa-b03c-920369410956

> FDA 483 for King Systems Corp. dba Ambu, Inc. on April 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: King Systems Corp. dba Ambu, Inc.
- Inspection Date: 2021-04-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of King Systems Corp. dba Ambu, Inc. in Noblesville, Indiana, from April 13-15, 2021, revealed a significant quality system deficiency. The firm failed to adequately document the results of its design risk analysis, specifically regarding mitigations for reversed images on the King Vision Video Laryngoscope Adapter. This issue highlights a lack of proper documentation and design input identification, which previously led to a device recall.

## Related Documents

- [WARNING_LETTER - 2013-08-14](https://www.keypedia.com/records/warning_letter/king-systems-corp-dba-ambu-inc/8c748ad6-da53-4651-b7fb-b6d1ff7ca2e2)
- [WARNING_LETTER - 2023-05-16](https://www.keypedia.com/records/warning_letter/king-systems-corp-dba-ambu-inc/94beb6e6-2816-4614-8de2-6ea6f7dee2a5)

## Related Officers

- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)

Company: https://www.keypedia.com/companies/king-systems-corp-dba-ambu-inc/323aebc9-9a8a-4c25-972e-c148400f9e6f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0