# FDA 483 - Hetero Labs Limited - Unit III - July 21, 2023

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/8eb74200-1af3-4dc8-9a05-2f583d07f9f3

> FDA 483 for Hetero Labs Limited - Unit III on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Labs Limited - Unit III
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hetero Labs, Ltd. - Unit III in Hyderabad, Telangana, India, a finished dosage drug manufacturer, revealed significant deficiencies in laboratory controls and quality systems. Observations included incomplete analytical data in laboratory records, lack of justification for LIMS changes, and insufficient raw data and impurity calculations. Additionally, the firm failed to maintain complete investigation records for unexplained discrepancies, leading to repeated deviations and ineffective corrective actions.

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## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)
- [Investigator ](https://www.keypedia.com/people/raquel-gonzalez-rivera/84cdd41f-b03c-4d13-a289-e2ebf4417c3c)

Company: https://www.keypedia.com/companies/hetero-labs-limited-unit-iii/8b051c13-41f2-4f52-a2cd-d5736ca72735

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