# FDA 483 - Hetero Labs Limited - Unit III - July 31, 2015

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/098a47d1-43ad-4275-b9d6-eb6b501b19fa

> FDA 483 for Hetero Labs Limited - Unit III on July 31, 2015. 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: 2015-07-31
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hetero Labs, Ltd. - Unit III in Hyderabad, India, from July 27-31, 2015, revealed significant deficiencies in laboratory controls. Specifically, the firm failed to conduct required hypothesis testing during out-of-specification investigations and did not adequately record incubation times for microbial analysis. These issues indicate a lack of scientifically sound and appropriate test procedures to ensure drug product quality.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/lucas-b-leake/f4c191d4-25d1-4eb8-8dc9-4d1aa483a441)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8