# FDA 483 - ACTA Laboratories, Inc. - January 19, 2018

Source: https://www.keypedia.com/records/483/acta-laboratories-inc/34bf9ad5-e96f-4fe2-82d5-b9390ea689aa

> FDA 483 for ACTA Laboratories, Inc. on January 19, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ACTA Laboratories, Inc.
- Inspection Date: 2018-01-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of ACTA Laboratories, Inc. in Foothill Ranch, CA, revealed significant deficiencies in laboratory controls and data integrity. The firm failed to verify testing methods, lacked appropriate controls over computerized systems, and did not maintain written records of investigations into unexplained discrepancies. These issues indicate a lack of robust quality systems for pharmaceutical testing and data management.

## Related Documents

- [483 - 2023-02-13](https://www.keypedia.com/records/483/acta-laboratories-inc/fd8b0370-6612-4fb9-b6b4-609d11fb0cf2)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)
- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

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