# FDA 483 - GUANGDONG BIOLIGHT MEDITECH CO., LTD - September 05, 2024

Source: https://www.globalkeysolutions.net/records/483/guangdong-biolight-meditech-co-ltd/6e9fddb7-f444-4c46-96e9-913fcb96bffe

> FDA 483 for GUANGDONG BIOLIGHT MEDITECH CO., LTD on September 05, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GUANGDONG BIOLIGHT MEDITECH CO., LTD
- Inspection Date: 2024-09-05
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of GUANGDONG BIOLIGHT MEDITECH CO., LTD, a class II medical device manufacturer in Zhuhai, Guangdong, China, revealed two significant observations. The firm lacked adequate procedures for design changes, specifically regarding software compilation and bug mitigation for their pulse oximeters. Additionally, the company failed to establish procedures to justify sampling sizes used in design and process validation/verification activities.

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