# FDA 483 - Lights Medical Manufacture Co Ltd - November 08, 2024

Source: https://www.globalkeysolutions.net/records/483/lights-medical-manufacture-co-ltd/6723e899-f226-458e-8fb6-ad7f1df83568

> FDA 483 for Lights Medical Manufacture Co Ltd on November 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lights Medical Manufacture Co Ltd
- Inspection Date: 2024-11-08
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Lights Medical Manufacture Co., Ltd in Tianjin, China, a drug manufacturer, revealed two significant observations. The firm failed to follow its own quality unit procedures regarding change control for critical testing equipment and did not maintain written equipment use logs for manufacturing equipment used in producing over-the-counter drug products.

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/lights-medical-manufacture-co-ltd/f43047d3-9a5f-427d-bdc4-6a89acf80f66

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