# Hetero Labs Limited (Unit V) – FDA 483, Aug 7, 2026

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/9b91dcfc-6100-48c1-9899-732b42ec1cc6

> FDA 483 for Hetero Labs Limited (Unit V) on August 07, 2026. 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: 2026-08-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hetero Labs Limited (Unit V) in Mahabubnagar, India, was cited for significant deficiencies in drug manufacturing practices during an FDA inspection. The firm failed to establish adequate process controls and validation for drug products, neglected to properly test raw materials, and maintained equipment in a condition that could lead to contamination. These issues indicate a lack of control over critical aspects of drug product quality and purity.

## Related Documents

- [EIR - 2022-08-12](https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/d1f1d760-4646-478f-9190-3ea372d7cb76) — date: August 12, 2022
- [483 - 2022-08-12](https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/86a09275-ffe8-45a7-bdef-0fdf8a394ef9) — date: August 12, 2022
- [EIR - 2016-12-16](https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/d5648335-9764-4837-91ee-29f8eedcdcbd) — date: December 16, 2016
- [483 - 2016-12-16](https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/35e291f3-ffb9-4d4a-86cb-ac56e0d994fa) — date: December 16, 2016

## Related Officers

- [John D. McIntosh](https://www.keypedia.com/people/john-d-mcintosh/063cac5b-0933-4ecf-a9fb-835dd5d25ef2)
- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

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

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