# FDA 483 - AMCO International Manufacturing & Design, Inc. - March 20, 2024

Source: https://www.keypedia.com/records/483/amco-international-manufacturing-design-inc/d31530cd-5384-400b-a763-cb6984757417

> FDA 483 for AMCO International Manufacturing & Design, Inc. on March 20, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMCO International Manufacturing & Design, Inc.
- Inspection Date: 2024-03-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: AMCO International Manufacturing & Design, Inc. in Brooklyn, NY, a manufacturer of Class III AED batteries, was cited for significant deficiencies in its quality system. Observations included a deficient design history file for a new AED battery, inadequate process controls for ESD-sensitive components, and a lack of documented equipment calibration and maintenance. These issues indicate a serious lack of control over critical manufacturing processes and product design.

## Related Documents

- [483 - 2021-05-27](https://www.keypedia.com/records/483/amco-international-manufacturing-design-inc/b00021a5-09e4-4f00-b1c2-753318dbc469)
- [WARNING_LETTER - 2024-03-20](https://www.keypedia.com/records/warning_letter/amco-international-manufacturing-design-inc/9ef2cd8f-b00a-4e21-8518-3eea107981f3)

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/amco-international-manufacturing-design-inc/d83d67ac-3fc8-49f1-b009-258ee8b8681a

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