# FDA 483 - Aware Environmental Pty Ltd - July 09, 2019

Source: https://www.keypedia.com/records/483/aware-environmental-pty-ltd/3cc6f7fb-d79c-4b7a-8f0f-47b29e781ad3

> FDA 483 for Aware Environmental Pty Ltd on July 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aware Environmental Pty Ltd
- Inspection Date: 2019-07-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Scental Pacific Pty. Ltd. in Bayswater, Australia, revealed widespread deficiencies across its quality, production, packaging, labeling, facilities, equipment, and laboratory control systems. The firm failed to adhere to its own standard operating procedures, adequately qualify personnel and equipment, validate manufacturing processes and test methods, and maintain complete and accurate records for drug products shipped to the U.S. These systemic issues indicate a significant lack of control over critical aspects of drug manufacturing and quality assurance.

## Related Officers

- [Angela Glenn](https://www.keypedia.com/people/angela-glenn/5ba5e1e2-883b-42c4-aae0-3564820723e8)

Company: https://www.keypedia.com/companies/aware-environmental-pty-ltd/fc2bf13a-7238-479e-a199-3e17ca1cc00f

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