# FDA 483 - Bora Pharmaceuticals Laboratories, Inc - July 21, 2025

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-laboratories-inc/41f5d802-3a4f-46ad-a5be-eb1bbd4fb683

> FDA 483 for Bora Pharmaceuticals Laboratories, Inc on July 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Laboratories, Inc
- Inspection Date: 2025-07-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Bora Pharmaceuticals Laboratories, Inc. in Zhunan Township, Taiwan, received an FDA Form 483 citing multiple significant deficiencies. These included inadequate production and process controls, failure to thoroughly review unexplained discrepancies, and non-adherence to complaint handling procedures. Additionally, master production records lacked complete instructions, and the annual quality standards evaluation used a deficient sampling plan for retain samples.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/bora-pharmaceuticals-laboratories-inc/9bb86ed9-7d7d-4886-a145-b9497462c295

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8