# FDA 483 - Hetero Labs Limited - Unit III - June 07, 2019

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/36e5da2c-e813-4ebd-a09d-d5e8f71f6cd7

> FDA 483 for Hetero Labs Limited - Unit III on June 07, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hetero Labs Limited - Unit III
- Inspection Date: 2019-06-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hetero Labs, Ltd. - Unit III, a finished dosage drug manufacturer in Hyderabad, India, was cited for significant deficiencies across its quality systems. The inspection revealed widespread issues including inadequate computer system controls, lack of written procedures for critical manufacturing processes, insufficient investigations into discrepancies, and failures in laboratory instrument calibration and sample management. These observations indicate a systemic lack of control over manufacturing and quality operations, posing a high risk to product quality and data integrity.

## Related Documents

- [483 - 2015-07-31](https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/098a47d1-43ad-4275-b9d6-eb6b501b19fa)
- [483 - 2016-10-26](https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/fa0b075a-8c85-4400-99f8-c168a0ed26ed)
- [483 - 2018-03-23](https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/d1ca9b7b-3013-41e7-88ec-e22d4393afa4)
- [483 - 2018-10-26](https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/3adb6ed3-d4b8-482d-aecf-624f8ceb7aa5)
- [483 - 2023-07-21](https://www.keypedia.com/records/483/hetero-labs-limited-unit-iii/8eb74200-1af3-4dc8-9a05-2f583d07f9f3)

## Related Officers

- [Miguel A. Martinez](https://www.keypedia.com/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)
- [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