# FDA 483 - Soaptronic LLC - February 14, 2020

Source: https://www.keypedia.com/records/483/soaptronic-llc/c78ecc16-78fb-4eb1-8d1a-a1cce2b7d7d4

> FDA 483 for Soaptronic LLC on February 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Soaptronic LLC
- Inspection Date: 2020-02-14
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Centronic LLC, a manufacturing facility in Lake Forest, CA, was inspected by the FDA from February 12-14, 2020. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate personnel, insufficient training, failure to reject out-of-specification raw materials, deficient laboratory controls, and compromised data integrity for electronic records. These issues indicate a serious lack of control over drug product manufacturing and quality assurance.

## Related Documents

- [WARNING_LETTER - 2019-12-12](https://www.keypedia.com/records/warning_letter/soaptronic-llc/2ebffc45-180a-48d6-b4c5-c21b930926d7)
- [483 - 2025-04-28](https://www.keypedia.com/records/483/soaptronic-llc/3adde245-f5b8-4bde-8ec5-1d89f4937091)

## Related Officers

- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)
- [Li Chin](https://www.keypedia.com/people/li-chin/bc82b3d3-6416-4da2-9161-c8e0c8a09bac)
- [Claudia M. Perez-Kasmarski](https://www.keypedia.com/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

Company: https://www.keypedia.com/companies/soaptronic-llc/6b9eb3e6-c92b-40be-a2d2-aadb5c931099

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