# FDA 483 - Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant, Research Building - November 04, 2022

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-ophthalmic-inc-taoyuan-plant-research-building/dafae910-e712-42ce-87cf-5ae6014f567e

> FDA 483 for Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant, Research Building on November 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant, Research Building
- Inspection Date: 2022-11-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Synpac-Kingdom Pharmaceutical Company Ltd in Taoyuan City, Taiwan, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production and process controls, inadequate validation of aseptic processes for sterile drug products, and a failure to thoroughly investigate unexplained discrepancies and out-of-specification results. These issues indicate a lack of robust quality control and assurance for drug product identity, strength, quality, and purity.

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/bora-pharmaceuticals-ophthalmic-inc-taoyuan-plant-research-building/a121d0e3-7783-4d68-9a26-cd6e2df3a352

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