# FDA 483 - Hikal Limited - August 01, 2019

Source: https://www.keypedia.com/records/483/hikal-limited/95f89445-c3bd-4ff9-a0f2-92f1aeb9df09

> FDA 483 for Hikal Limited on August 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hikal Limited
- Inspection Date: 2019-08-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An inspection of Hikal Limited, an active pharmaceutical manufacturer in Anekal Taluk, Bangalore, revealed significant deficiencies in their laboratory procedures and record-keeping practices. Specifically, records for microbial testing were not completed at the time of performance, and documentation for bioburden analysis was found to be inadequate. These issues impact drug substances intended for both European and US markets.

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## Related Officers

- [investigator](https://www.keypedia.com/people/maria-estrella/36cf1d7d-41af-4f40-9de4-174a82a31a56)

Company: https://www.keypedia.com/companies/hikal-limited/cb3e9445-04eb-4d52-af78-793b43f9d61f

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