# FDA 483 - Symed Labs Limited (Unit I) - December 06, 2024

Source: https://www.keypedia.com/records/483/symed-labs-limited-unit-i/51086503-a065-4e12-b441-265f2b71778e

> FDA 483 for Symed Labs Limited (Unit I) on December 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symed Labs Limited (Unit I)
- Inspection Date: 2024-12-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Symed Labs Limited (Unit I), an API manufacturer, received a Form 483 for significant deficiencies in its quality systems. The firm failed to establish adequate written procedures for production and process controls, including insufficient process validation for critical changes and lack of equipment qualification. Additionally, the inspection revealed a lack of proper written procedures for equipment cleaning and maintenance, impacting the quality assurance of drug substances.

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/symed-labs-limited-unit-i/6687f07e-a946-4527-86e8-687f0ec46c66

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