# FDA 483 - Hetero Labs Limited - August 12, 2021

Source: https://www.globalkeysolutions.net/records/483/hetero-labs-limited/7d2c6d97-b1dd-4fc5-90a4-0d65caaa4c3f

> FDA 483 for Hetero Labs Limited on August 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Labs Limited
- Inspection Date: 2021-08-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hetero Labs Limited, an API manufacturer in Sanga Reddy District, Telangana, India, revealed multiple significant deficiencies. The firm failed to establish appropriate specifications for APIs, validate test procedures for impurities, and ensure adequate cleaning and maintenance of manufacturing equipment. These issues indicate a lack of control over product quality and purity, potentially impacting APIs supplied to the US market.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/hetero-labs-limited/9dc957f3-0e7b-4669-b7aa-b9f02548ca3f)
- [483 - 2023-09-08](https://www.globalkeysolutions.net/records/483/hetero-labs-limited/912c5b51-4aa0-4de7-a79d-557cdf487904)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/hetero-labs-limited/511d3250-3361-4a46-af69-a80476303c91

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