# FDA 483 - Lantech Pharmaceuticals Ltd. - March 15, 2019

Source: https://www.keypedia.com/records/483/lantech-pharmaceuticals-ltd/d41b7051-3a59-407e-a5a9-0a2c1624dea4

> FDA 483 for Lantech Pharmaceuticals Ltd. on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lantech Pharmaceuticals Ltd.
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lantech Pharmaceuticals Ltd., an API manufacturer in Chittivalasa, India, received a Form FDA 483 with nine observations during an inspection from March 6-15, 2019. The observations highlight significant deficiencies across quality systems, including inadequate investigations, poor equipment cleaning, lack of electronic data control, insufficient Quality Unit oversight, and absence of process validation for solvent recovery. These issues indicate a systemic failure to ensure product quality and data integrity.

## Related Officers

- [Performance Improvement Coordinator](https://www.keypedia.com/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)
- [investigator](https://www.keypedia.com/people/eric-dong/762c3fe2-593d-41b6-8903-7c354f732435)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/lantech-pharmaceuticals-ltd/41b9d7a6-5661-4098-9a4d-1dcbc8eb222f

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