# FDA 483 - AIE Pharmacueticals, Inc. - September 17, 2021

Source: https://www.keypedia.com/records/483/aie-pharmacueticals-inc/c3f7ab59-f8ee-4524-8460-b865e74c94ac

> FDA 483 for AIE Pharmacueticals, Inc. on September 17, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIE Pharmacueticals, Inc.
- Inspection Date: 2021-09-17
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: AIE Pharmacueticals, Inc. in Ontario, CA, a dietary supplement manufacturer, received eight observations during an FDA inspection. The firm was cited for significant deficiencies across its manufacturing processes, including a lack of established specifications for components and finished products, inadequate contamination prevention, and incomplete master and batch production records. These issues highlight a systemic failure in quality control operations, indicating a high severity of non-compliance with good manufacturing practices.

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Company: https://www.keypedia.com/companies/aie-pharmacueticals-inc/b1decb50-7862-409e-bfb1-bfa8b55fccd5

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6