# FDA 483 - Encube Ethicals Pvt. Ltd. - June 11, 2019

Source: https://www.keypedia.com/records/483/encube-ethicals-pvt-ltd/dbcd143f-75b3-4046-8504-6c816ad9b1c0

> FDA 483 for Encube Ethicals Pvt. Ltd. on June 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Encube Ethicals Pvt. Ltd.
- Inspection Date: 2019-06-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Encube Ethicals Pvt. Ltd. in Ponda, India, a topical contract manufacturer, was cited for significant deficiencies in its laboratory controls, equipment maintenance, and complaint handling during an FDA inspection. Observations included inadequate OOS investigations, improper storage of reference standards, incomplete laboratory records, and a failure to thoroughly investigate customer complaints, indicating systemic issues with quality control and documentation.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.keypedia.com/companies/encube-ethicals-pvt-ltd/2bba05cc-6e4f-4020-8f97-3e56020b33a2

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