# FDA 483 - ACTA Laboratories, Inc. - February 13, 2023

Source: https://www.keypedia.com/records/483/acta-laboratories-inc/fd8b0370-6612-4fb9-b6b4-609d11fb0cf2

> FDA 483 for ACTA Laboratories, Inc. on February 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACTA Laboratories, Inc.
- Inspection Date: 2023-02-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: ACTA Laboratories, Inc. in Foothill Ranch, CA, was inspected and received a Form 483 with three observations. The inspection revealed significant issues with the quality control unit's procedures, including failures in stability program investigations, sample processing, and lack of written procedures for critical activities. Additionally, deficiencies were noted in ongoing GMP training for employees and adherence to written sanitation procedures, with evidence of pest activity.

## Related Documents

- [483 - 2018-01-19](https://www.keypedia.com/records/483/acta-laboratories-inc/34bf9ad5-e96f-4fe2-82d5-b9390ea689aa)

## Related Officers

- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/acta-laboratories-inc/215a2fac-a2d0-4b2e-b8ca-8c9abe4cbb7d

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