# FDA 483 - Hetero Labs Limited - Unit III - October 26, 2016

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/fa0b075a-8c85-4400-99f8-c168a0ed26ed

> FDA 483 for Hetero Labs Limited - Unit III on October 26, 2016. 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: 2016-10-26
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Hetero Labs, Ltd. - Unit III received a Form 483 for significant deficiencies in laboratory controls and record-keeping. The firm failed to use validated and transferred analytical methods for various product testing stages and did not adequately investigate out-of-trend results. Additionally, laboratory records were incomplete and lacked proper documentation practices.

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## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321