# FDA 483 - Hetero Labs Limited (Unit V) - December 16, 2016

Source: https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/35e291f3-ffb9-4d4a-86cb-ac56e0d994fa

> FDA 483 for Hetero Labs Limited (Unit V) on December 16, 2016. 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: 2016-12-16
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in quality control, record-keeping, manufacturing processes, complaint handling, equipment maintenance, and data integrity.

**Observation 1: Quality Control Unit Responsibilities and Procedures Not Fully Followed**
The firm's QA technicians and other individuals were observed destroying and altering commercial batch manufacturing records immediately prior to the inspection. Evidence includes:
*   A document shredder introduced into the "DOCUMENTS STORAGE AREA" four days before the inspection.
*   Extensive shredding of what appeared to be controlled documents (batch packaging and manufacturing records) and extensive signing of documents by QA. The firm failed to maintain a log of shredded documents.
*   A contract QA employee removing documents from the shredder and placing them in his pocket.
*   Individuals shredding documents in the middle of the night, which the firm attributed to cleaning staff.
*   Discarded controlled documents, including a post-dated balance printout for drug product (b)(4) (indicating date alteration), a "GMP REPORT" with a "PASS" result, an "Abort" event printout, and numerous documents with written numbers and signatures found in the scrap area.
*   Controlled documents, including original test results and cleanroom certification reports, found in trash bins. The firm's Quality Manager admitted failure to maintain a shred log, violating SOP QA001-11 regarding document loss prevention.

## Related Documents

- [EIR - 2015-05-01](https://www.keypedia.com/records/eir/hetero-labs-limited-unit-v/d5648335-9764-4837-91ee-29f8eedcdcbd)
- [483 - 2022-08-12](https://www.keypedia.com/records/483/hetero-labs-limited-unit-v/86a09275-ffe8-45a7-bdef-0fdf8a394ef9)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [Biologist at CBER](https://www.keypedia.com/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c