# FDA 483 - Lofty Laboratories Private Limited - August 04, 2022

Source: https://www.globalkeysolutions.net/records/483/lofty-laboratories-private-limited/701429d4-ee2a-4c36-963c-f6b95639f261

> FDA 483 for Lofty Laboratories Private Limited on August 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lofty Laboratories Private Limited
- Inspection Date: 2022-08-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Lofty Laboratories Private Limited in Pashamylaram, India, revealed significant deficiencies in laboratory controls and quality systems. The firm failed to adequately investigate unexplained discrepancies, including HPLC system suitability failures and column leakages. Additionally, their HPLC test methods for intermediate drug substances lacked established system suitability runs prior to analysis.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.globalkeysolutions.net/companies/lofty-laboratories-private-limited/1dc376ed-6d5d-4f20-ac14-05e4a18b32e8

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