# FDA 483 - Hetero Labs Limited - Unit III - March 23, 2018

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/d1ca9b7b-3013-41e7-88ec-e22d4393afa4

> FDA 483 for Hetero Labs Limited - Unit III on March 23, 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: 2018-03-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hetero Labs, Ltd. - Unit III, a drug manufacturer in Hyderabad, India, was cited for significant deficiencies in its manufacturing and laboratory controls. Observations included incomplete master production records lacking detailed sampling procedures, failure to adhere to the stability testing program's timelines, and inadequate laboratory records missing documentation of reference standards, equipment, and reagents. These issues indicate a lack of robust quality control and record-keeping practices.

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## Related Officers

- [Rita Kabaso](https://www.keypedia.com/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

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