# FDA 483 - Therapak Corporation - February 12, 2026

Source: https://www.keypedia.com/records/483/therapak-corporation/93e788d2-6c1e-452f-a54b-45c9720682d4

> FDA 483 for Therapak Corporation on February 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Therapak Corporation
- Inspection Date: 2026-02-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Therapak Corporation, a contract manufacturer in Claremont, CA, revealed significant deficiencies in their quality management system. The firm failed to properly utilize data analysis for improvement, specifically demonstrating erroneous statistical sampling for both receiving inspection and manufacturing of medical devices. Additionally, procedures for the feedback process, particularly regarding complaint handling and risk categorization, were found to be undocumented or improperly applied.

## Related Officers

- [Linda Galindo](https://www.keypedia.com/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.keypedia.com/companies/therapak-corporation/1a9ffab2-008a-4396-9e24-94bdc8fa916e

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6