# FDA 483 - Rochal Technologies - August 01, 2024

Source: https://www.keypedia.com/records/483/rochal-technologies/59c6f1f0-1161-4f9a-af47-f5cd08e9d567

> FDA 483 for Rochal Technologies on August 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rochal Technologies
- Inspection Date: 2024-08-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/rochal-technologies/6c3ec532-f3cf-44fa-aa49-7552f02f355e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab