# FDA 483 - Allied Pharmacy Products. Inc. - March 13, 2019

Source: https://www.keypedia.com/records/483/allied-pharmacy-products-inc/c1b7bfa8-3a76-4b82-9f12-cbab32835af2

> FDA 483 for Allied Pharmacy Products. Inc. on March 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allied Pharmacy Products. Inc.
- Inspection Date: 2019-03-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of ALLIED PHARMACY PRODUCTS, INC. in Hicksville, NY, from March 11-13, 2019, revealed a significant quality system deficiency. The firm failed to establish a design history file for multiple Steri-Tamp seal products. This indicates a lack of proper documentation for the design and development of their medical devices.

## Related Documents

- [483 - 2023-01-10](https://www.keypedia.com/records/483/allied-pharmacy-products-inc/806816b2-46c3-4096-8831-9f08763c0128)

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/allied-pharmacy-products-inc/f77359cc-f73e-4fad-917a-f40629ed8e2d

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