SCHOTT CR, S.R.O.August 16, 2019

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

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Record Details

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.

Company: SCHOTT CR, S.R.O.
Inspection Date: August 16, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: James R. Montero

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ID · c2623587-455e-4628-ac27-83682abe3779