# FDA 483 - Advanced Pharmaceutical Technology Inc. - August 01, 2024

Source: https://www.keypedia.com/records/483/advanced-pharmaceutical-technology-inc/a51e160e-4349-4398-8605-e950e379aaa2

> FDA 483 for Advanced Pharmaceutical Technology Inc. on August 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Pharmaceutical Technology Inc.
- Inspection Date: 2024-08-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Advanced Pharmaceutical Technology Inc. in Elmsford, NY, a drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to ensure proper testing and release of drug products, lacked adequate quality control oversight for contract manufacturers and laboratories, and exhibited major issues with process validation, sterilization validation, and stability testing for its subcutaneous pellet products. Additionally, the inspection revealed deficient batch records, unmonitored drug storage conditions, and the use of unqualified API suppliers, indicating a broad breakdown in GMP compliance.

## Related Documents

- [483 - 2019-09-27](https://www.keypedia.com/records/483/advanced-pharmaceutical-technology-inc/f554ce69-54a7-4473-9f5d-29ab26519a02)
- [483 - 2021-08-23](https://www.keypedia.com/records/483/advanced-pharmaceutical-technology-inc/2dc3b6b1-ea4d-4bc0-a861-d05d1e11d653)
- [WARNING_LETTER - 2024-08-01](https://www.keypedia.com/records/warning_letter/advanced-pharmaceutical-technology-inc/c6419d57-e503-4182-8f1e-3bcd99606180)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.keypedia.com/companies/advanced-pharmaceutical-technology-inc/7eb3cf89-440c-4d2f-9371-3500b12e7fa2

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961