# FDA 483 - Encube Ethicals Pvt. Ltd. - June 17, 2024

Source: https://www.keypedia.com/records/483/encube-ethicals-pvt-ltd/3aae6501-1ae4-494b-b122-9db545472c2f

> FDA 483 for Encube Ethicals Pvt. Ltd. on June 17, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Encube Ethicals Pvt. Ltd.
- Inspection Date: 2024-06-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Encube Ethicals Private Limited, a topical manufacturer in Ponda, Goa, India, revealed numerous significant deficiencies across its quality system, facilities, equipment, material handling, production, and laboratory controls. The firm failed to adequately investigate out-of-specification results, lacked established procedures for critical manufacturing processes and equipment, and exhibited poor documentation practices. These issues indicate a systemic lack of control over manufacturing and quality operations, potentially impacting product quality and patient safety.

## Related Documents

- [483 - 2019-06-11](https://www.keypedia.com/records/483/encube-ethicals-pvt-ltd/dbcd143f-75b3-4046-8504-6c816ad9b1c0)

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

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