Rochal TechnologiesAugust 1, 2024

FDA 483 - Rochal Technologies - August 01, 2024

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Record Details

Rochal Technologies, a specification developer in San Antonio, TX, received two observations during an FDA inspection. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, leading to numerous device reports not being properly documented or evaluated. Additionally, procedures for the rework of nonconforming products were not adequately established, resulting in insufficient documentation of rework activities.

Company: Rochal Technologies
Inspection Date: August 1, 2024
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Christine I. Shaw (investigator)

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ID · 59c6f1f0-1161-4f9a-af47-f5cd08e9d567