# FDA 483 - Alkem Laboratories Limited - February 21, 2020

Source: https://www.keypedia.com/records/483/alkem-laboratories-limited/d071b888-452f-4a4b-ad30-6233268ad64d

> FDA 483 for Alkem Laboratories Limited on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Alkem Laboratories Limited, a drug manufacturer in Baddi, India, received an FDA Form 483 citing two observations related to quality control and equipment validation. The firm failed to perform a Performance Qualification for equipment used in drug product inspection and did not conduct an Out-of-Specification investigation for a Total Organic Carbon system failure. These deficiencies indicate a need for improved adherence to manufacturing and quality system regulations.

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## Related Officers

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Company: https://www.keypedia.com/companies/alkem-laboratories-limited/308e3070-8ca9-4084-a117-315b7e3f8ba8

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1