# FDA 483 - Tripak Pharmaceuticals Pty Ltd - July 25, 2025

Source: https://www.keypedia.com/records/483/tripak-pharmaceuticals-pty-ltd/6187bf11-548e-47b0-9873-54c6d60d86a6

> FDA 483 for Tripak Pharmaceuticals Pty Ltd on July 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tripak Pharmaceuticals Pty Ltd
- Inspection Date: 2025-07-25
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Tripak Pharmaceuticals Pty Ltd in Capalaba, Australia, received a Form 483 with nine observations following an FDA inspection. The observations highlight significant deficiencies in quality control, raw material testing, process validation, finished product release testing, stability programs, hold time studies, laboratory controls, equipment labeling, and labeling storage. These issues indicate a systemic failure to ensure drug product quality, identity, strength, and purity, potentially compromising patient safety for products shipped to the US market.

## Related Officers

- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.keypedia.com/companies/tripak-pharmaceuticals-pty-ltd/ec54974f-b671-4410-855e-6a7278ca7ce0

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