# FDA 483 - Lake Chemicals Private Limited - August 05, 2019

Source: https://www.globalkeysolutions.net/records/483/lake-chemicals-private-limited/98b6cb61-867e-402f-8d89-aca7e05054d3

> FDA 483 for Lake Chemicals Private Limited on August 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lake Chemicals Private Limited
- Inspection Date: 2019-08-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Lake Chemicals Pvt. Ltd. in Bangalore, India, revealed significant deficiencies in laboratory controls and facility maintenance for Active Pharmaceutical Ingredients (APIs). Issues included uncontrolled and incomplete laboratory records, lack of complete data, and poor building maintenance with water leaks and unlabeled equipment. These findings indicate a serious lack of adherence to good manufacturing practices.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/lake-chemicals-private-limited/a86572a4-5838-4fb9-90f8-b43e07c99b4a

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