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

Source: https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/7ee91b67-99ad-4f23-87b7-e97eea69b44a

> FDA EIR 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: EIR
- Company Name: Hetero Labs Limited (Unit V)
- Inspection Date: 2022-08-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hetero Labs Limited (Unit V), a finished drug product manufacturer, was conducted from August 4 to August 12, 2022. This comprehensive "for-cause" follow-up inspection, performed under Compliance Programs 7356.0002 for Drug Manufacturing Inspections and 7356.021B for Field Alert Reports, identified six significant deficiencies, detailed in a Form FDA-483. Main violations included the quality control unit not fully adhering to its responsibilities, inadequate records for drug complaint investigations, and a failure to submit Field Alert Reports within three working days for out-of-specification batches. Additionally, employees lacked required training for manufacturing functions, written procedures for equipment cleaning and maintenance were not established or followed, and computer system controls for master production records were insufficient. This inspection followed a previous one in April 2019, which also resulted in observations regarding production controls and batch record documentation, itself prompted by a 2017 Warning Letter. The current inspection is classified as Official Action Indicated (OAI), with a warning letter recommended, indicating a critical failure in the firm's quality system. Hetero Labs Limited (Unit V) acknowledged the observations and committed to submitting a response within 15 business days, signifying that substantial corrective actions are required to address these persistent quality system failures and ensure product quality and purity.

## Related Documents

- [EIR - 2016-12-16](https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/e3f6eaf3-a25d-41c6-bc90-075ed923e897)
- [EIR - 2015-05-01](https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/d5648335-9764-4837-91ee-29f8eedcdcbd)
- [483 - 2016-12-16](https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/35e291f3-ffb9-4d4a-86cb-ac56e0d994fa)
- [483 - 2022-08-12](https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/86a09275-ffe8-45a7-bdef-0fdf8a394ef9)
- [EIR - 2022-08-12](https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/d1f1d760-4646-478f-9190-3ea372d7cb76)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Rita Kabaso](https://www.keypedia.com/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)
- [Compliance Officer at FDA](https://www.keypedia.com/people/christopher-d-leach/2a3c4b73-f082-4f33-aa2d-52d1abbb6d55)
- [District Team Leader / District Team Leader Trainer](https://www.keypedia.com/people/jason-f-chancey/d4176303-5063-4cdd-87ba-32763b0cf6d0)

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