# FDA 483 - Connectronics SRO - February 06, 2020

Source: https://www.keypedia.com/records/483/connectronics-sro/4547292d-8039-4d03-859c-4f4f73f985d1

> FDA 483 for Connectronics SRO on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Connectronics SRO
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: Connectronics SRO, a medical device manufacturer in Kladno, Czech Republic, was inspected by the FDA from February 3-6, 2020. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of non-conforming products, insufficient device history records, and the use of unapproved and obsolete documents. These issues indicate a moderate level of non-compliance with quality system regulations.

## Related Officers

- [Brittani N. Franklin](https://www.keypedia.com/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.keypedia.com/companies/connectronics-sro/bc2b1c31-792d-40d5-a052-8193cb4aaed8

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1