# FDA 483 - Hetero Labs Limited (Unit V) - August 12, 2022

Source: https://www.globalkeysolutions.net/records/483/hetero-labs-limited-unit-v/86a09275-ffe8-45a7-bdef-0fdf8a394ef9

> FDA 483 for Hetero Labs Limited (Unit V) on August 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Labs Limited (Unit V)
- Inspection Date: 2022-08-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hetero Labs Limited (Unit V) in Mahabubnagar, India, a finished dosage manufacturer, revealed significant deficiencies in its quality control unit, including inadequate cleaning validation, process capability assessments, and laboratory investigations. The firm also failed to properly investigate drug complaints, submit a required field alert report, ensure adequate employee training, maintain equipment cleanliness, and implement appropriate computer system controls. These observations indicate a broad range of issues impacting product quality and regulatory compliance.

## Related Documents

- [EIR - 2015-05-01](https://www.globalkeysolutions.net/records/eir/hetero-labs-limited-unit-v/d5648335-9764-4837-91ee-29f8eedcdcbd)
- [483 - 2016-12-16](https://www.globalkeysolutions.net/records/483/hetero-labs-limited-unit-v/35e291f3-ffb9-4d4a-86cb-ac56e0d994fa)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/hetero-labs-limited-unit-v/2d1a05bb-2577-4d77-9785-7fbfbe0ade5c

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