# Guangzhou PharmaLab Co., Ltd. – FDA 483, Aug 30, 2023

Source: https://www.keypedia.com/records/483/guangzhou-pharmalab-co-ltd/705e166a-ffba-4c5b-b441-a41460bdac84

> FDA 483 for Guangzhou PharmaLab Co., Ltd. on August 30, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guangzhou PharmaLab Co., Ltd.
- Inspection Date: 2023-08-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Guangzhou PharmaLab Co., Ltd., a contract research organization in Guangzhou, China, received a Form 483 for significant deficiencies in data integrity and quality control. The inspection revealed a lack of appropriate controls over computerized systems, including selective data export and improper use of administrative accounts. Additionally, the quality unit failed to thoroughly investigate out-of-expectation results, did not follow established procedures for sample analysis, and lacked proper method transfer and communication processes with its contract laboratory.

## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.keypedia.com/companies/guangzhou-pharmalab-co-ltd/61032ac2-8cc8-4c4f-95a9-32c49679642b

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8