# FDA 483 - Asept Pak Inc. - August 04, 2023

Source: https://www.keypedia.com/records/483/asept-pak-inc/4b65dd02-8880-4aca-b99d-8dda285806f0

> FDA 483 for Asept Pak Inc. on August 04, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asept Pak Inc.
- Inspection Date: 2023-08-04
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Asept Pak Inc. in Malone, NY, a contract manufacturer of sterile products, received a Form FDA-483 citing two significant observations. The firm failed to adequately document corrective and preventive action activities, with multiple CAPA files remaining open past their due dates without proper extensions. Additionally, the inspection revealed a lack of documented periodic inspections and preventative maintenance for several critical equipment assets used in the aseptic filling process.

## Related Documents

- [WARNING_LETTER - 2012-06-20](https://www.keypedia.com/records/warning_letter/asept-pak-inc/764fcf8e-86d0-4e72-8f9f-bc95fceea9c3)
- [483 - 2019-12-20](https://www.keypedia.com/records/483/asept-pak-inc/b7e44fa7-47c5-47dd-97d1-802a5f66f1d2)

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94