# FDA 483 - Hetero Labs Limited - Unit III - October 26, 2018

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/3adb6ed3-d4b8-482d-aecf-624f8ceb7aa5

> FDA 483 for Hetero Labs Limited - Unit III on October 26, 2018. 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: 2018-10-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hetero Labs, Ltd. - Unit III in Hyderabad, India, revealed significant deficiencies in their drug manufacturing processes. Observations included a lack of established control procedures to monitor output and validate manufacturing process performance, leading to inconsistent processes and failed batches. Additionally, master production and control records were found to be missing theoretical yield specifications.

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## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

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