# FDA 483 - Advanced Pharmaceutical Technology Inc. - August 23, 2021

Source: https://www.keypedia.com/records/483/advanced-pharmaceutical-technology-inc/2dc3b6b1-ea4d-4bc0-a861-d05d1e11d653

> FDA 483 for Advanced Pharmaceutical Technology Inc. on August 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Pharmaceutical Technology Inc.
- Inspection Date: 2021-08-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Advanced Pharmaceutical Technology Inc. in Elmsford, NY, was inspected by the FDA from August 5-23, 2021, and received a Form 483 with seven observations. The inspection revealed significant deficiencies in quality control, manufacturing process validation, stability testing, equipment cleaning procedures, supplier qualification, and employee training for their Testosterone and Estradiol Subcutaneous Pellet drug products. These issues indicate a lack of adherence to cGMP requirements, posing potential risks to product quality and patient safety.

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## Related Officers

- [Vivin George](https://www.keypedia.com/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [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