# FDA 483 - Rochal Technologies - August 01, 2024

Source: https://www.keypedia.com/records/483/rochal-technologies/36ff0139-4abc-4380-acb6-ec73882901ca

> FDA 483 for Rochal Technologies on August 01, 2024. Product: devices. 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: devices
- Office Name: Dallas District Office
- Summary: Rochal Technologies, a specification developer, underwent an FDA inspection from July 29 to August 1, 2024. The inspection revealed two significant observations related to the company's quality system, as outlined in a Form FDA-483.

The first observation concerned inadequate procedures for handling complaints. Specifically, the firm's complaint handling process, governed by SOP-3, failed to ensure proper documentation, review, and evaluation of complaints by a designated unit. For example, 36 reports of leaking bags for their Sterile Class II BIASURGE Advanced Surgical Solution devices, received since July 2022, were not documented or assessed as complaints, and no Medical Device Report (MDR) evaluations were performed.

The second observation highlighted insufficient procedures for the rework of nonconforming products. SOP-23, addressing nonconforming products, did not ensure that rework activities, whether internal or performed by a third-party warehouse, were adequately documented. This included a lack of documentation for training, assessment of adverse impacts, and reinspection after rework. An instance cited involved inadequate documentation for the rework of Class II Antimicrobial Skin and Wound Cleanser devices with labeling nonconformances.

These observations indicate areas where Rochal Technologies needs to enhance its adherence to regulatory quality system requirements. The company has committed to correcting both issues.

## Related Documents

- [483 - 2024-08-01](https://www.keypedia.com/records/483/rochal-technologies/59c6f1f0-1161-4f9a-af47-f5cd08e9d567)

## Related Officers

- [Jose E. Almeida](https://www.keypedia.com/people/jose-e-almeida/1df7930c-d835-4c16-85a0-4c9adbb531a4)
- [Christine Drabick](https://www.keypedia.com/people/christine-drabick/c2d1af39-8ad5-4f70-84cc-19548f8fa3d0)
- [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/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9