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

Source: https://www.keypedia.com/records/483/encube-ethicals-pvt-ltd/426ba7db-d3e2-4180-ae04-d293a23c4368

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

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## Details

- Record Type: 483
- Company Name: Encube Ethicals Pvt. Ltd.
- Inspection Date: 2024-06-17
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: During an inspection from June 11-17, 2024, the FDA issued a Form 483 to Encube Ethicals Private Limited, a topical drug manufacturer in Ponda, Goa, India. The inspection revealed significant deficiencies across multiple quality systems, indicating a failure to adhere to Good Manufacturing Practices (GMP). Key violations included a systemic failure to thoroughly investigate Out-of-Specification (OOS) results, particularly regarding product assay and stability, with instances of invalidating data without scientific justification and inadequate root cause analysis. The firm lacked established bulk and equipment clean/dirty hold times, operated with unvalidated equipment changes, and exhibited poor control over change management. Additionally, the Quality Control unit failed to establish proper procedures for equipment requalification and maintain training records for corporate personnel overseeing GMP operations. Further issues involved facility maintenance, such as leaking water systems, and inadequate segregation of bulk materials in packaging rooms, increasing contamination risks. Equipment cleaning status was often unlabeled, and foreign objects were found in production areas. Record-keeping practices were deficient, with critical calculation documents found discarded and non-contemporaneous entries in batch records. Laboratory controls were also cited for inadequate documentation of sample handling and stability studies. Encube Ethicals is required to submit a comprehensive response detailing corrective and preventive actions to address these observations and ensure compliance with FDA regulations, which govern the quality and safety of drug products.

## Related Documents

- [483 - 2019-06-11](https://www.keypedia.com/records/483/encube-ethicals-pvt-ltd/dbcd143f-75b3-4046-8504-6c816ad9b1c0)
- [483 - 2024-06-17](https://www.keypedia.com/records/483/encube-ethicals-pvt-ltd/3aae6501-1ae4-494b-b122-9db545472c2f)

## 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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa