# FDA 483 - Asept Pak Inc. - December 20, 2019

Source: https://www.globalkeysolutions.net/records/483/asept-pak-inc/b7e44fa7-47c5-47dd-97d1-802a5f66f1d2

> FDA 483 for Asept Pak Inc. on December 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asept Pak Inc.
- Inspection Date: 2019-12-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Asept Pak Inc. in Malone, NY, was cited for significant deficiencies during an FDA inspection from December 11-20, 2019. The observations highlight critical issues across manufacturing process validation, aseptic processing controls, product stability data, equipment maintenance, and quality control unit adherence. These findings indicate a severe lack of control over the manufacturing environment and processes for their sterile infant analgesic products, raising concerns about product quality and sterility.

## Related Documents

- [WARNING_LETTER - 2012-06-20](https://www.globalkeysolutions.net/records/warning_letter/asept-pak-inc/764fcf8e-86d0-4e72-8f9f-bc95fceea9c3)
- [483 - 2023-08-04](https://www.globalkeysolutions.net/records/483/asept-pak-inc/4b65dd02-8880-4aca-b99d-8dda285806f0)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/asept-pak-inc/76a8efb3-a596-4719-92c7-71568f29eb79

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