# FDA 483 - Alembic Pharmaceuticals Limited - Unknown Date

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/089e0b76-b314-449b-8ee8-280ef4484a66

> FDA 483 for Alembic Pharmaceuticals Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Alembic Pharmaceutical Limited (Formulation 1) in Panchmahal, Gujarat, India, a finished dosage manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included failures in quality control procedures related to product recall for a mislabeling event and deficient complaint handling. Further issues involved unauthorized access to label storage, inconsistent gowning practices, and inadequate challenging of camera equipment used for lot number printing verification.

## Related Documents

- [483 - 2016-03-25](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/b5435c4b-1323-4172-9f87-3079d507645c)
- [483 - 2018-03-20](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/a81be92f-aa80-44d2-a123-2cd68fca1582)

## Related Officers

- [investigator](https://www.keypedia.com/people/shirshendu-k-deb/d8e51b5d-e39c-46c5-893d-b01261babec4)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/alembic-pharmaceuticals-limited/922eba08-7d55-42d2-9d7e-d116c041af25

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