# FDA 483 - Symed Labs Limited - October 16, 2021

Source: https://www.keypedia.com/records/483/symed-labs-limited/053cab8d-207c-487b-9f3c-3aed1b549f61

> FDA 483 for Symed Labs Limited on October 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Symed Labs Limited
- Inspection Date: 2021-10-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Symed Labs Limited in Choutuppal, India, an Active Pharmaceutical Ingredient Intermediate Manufacturer, revealed significant deficiencies in equipment maintenance, laboratory controls, and computer system validation. Observations included leaking equipment with improper cleaning and inventory records, test methods lacking appropriate system suitability requirements, and the use of unvalidated software for critical chromatographic purity calculations. These issues raise concerns about the quality and purity of drug intermediates manufactured at the facility.

## Related Officers

- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/symed-labs-limited/e8f8c7d2-cf8d-4ce6-b9ca-0613fd2496dc

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1