# FDA 483 - AARTI PHARMALABS LIMITED - June 23, 2022

Source: https://www.globalkeysolutions.net/records/483/aarti-pharmalabs-limited/7ed711a7-42fc-45c4-a41b-f9540f5c8714

> FDA 483 for AARTI PHARMALABS LIMITED on June 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AARTI PHARMALABS LIMITED
- Inspection Date: 2022-06-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aarti Industries Limited, an API manufacturer in Dombivil (E), Thane, India, was cited for two observations during an FDA inspection. The firm failed to conduct temperature mapping studies for warehouses storing intermediate drug products with specific storage requirements. Additionally, the company did not perform analytical method verification studies for test methods transferred from a sponsor for API drug products.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/aarti-pharmalabs-limited/bf3ea5bb-53af-45fd-8d8f-0a2b18e6b738

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