# FDA 483 - Hetero Labs Limited - September 08, 2023

Source: https://www.globalkeysolutions.net/records/483/hetero-labs-limited/912c5b51-4aa0-4de7-a79d-557cdf487904

> FDA 483 for Hetero Labs Limited on September 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Labs Limited
- Inspection Date: 2023-09-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hetero Labs Ltd. Unit 1, an API manufacturer in Jinnaram Mandal, India, revealed significant deficiencies. Observations included non-contemporaneous laboratory data documentation and inadequate cleaning validation studies that failed to consider worst-case conditions. Furthermore, the firm's laboratory controls were found to be insufficient for ensuring conformance to specifications, and complaint investigations lacked thorough root cause analysis and comprehensive impact assessments.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/hetero-labs-limited/9dc957f3-0e7b-4669-b7aa-b9f02548ca3f)
- [483 - 2021-08-12](https://www.globalkeysolutions.net/records/483/hetero-labs-limited/7d2c6d97-b1dd-4fc5-90a4-0d65caaa4c3f)

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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