# FDA 483 - SCHOTT CR, S.R.O. - August 16, 2019

Source: https://www.keypedia.com/records/483/schott-cr-sro/c2623587-455e-4628-ac27-83682abe3779

> FDA 483 for SCHOTT CR, S.R.O. on August 16, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SCHOTT CR, S.R.O.
- Inspection Date: 2019-08-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: SCHOTT CR, S.R.O., a medical device manufacturer in Valasske Mezirici, Czech Republic, was inspected by the FDA. The inspection revealed two observations related to quality system deficiencies. Specifically, the firm failed to validate a critical manufacturing process and lacked established procedures for device history records.

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/schott-cr-sro/edce45a7-542a-4c89-8797-33fe4147abc9

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd