# FDA 483 - AMCO International Manufacturing & Design, Inc. - May 27, 2021

Source: https://www.globalkeysolutions.net/records/483/amco-international-manufacturing-design-inc/b00021a5-09e4-4f00-b1c2-753318dbc469

> FDA 483 for AMCO International Manufacturing & Design, Inc. on May 27, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: AMCO International Manufacturing & Design, Inc.
- Inspection Date: 2021-05-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: AMCO International Manufacturing & Design, Inc., a medical device manufacturer in Brooklyn, NY, was cited for two significant issues during an FDA inspection. The firm failed to maintain written Medical Device Reporting (MDR) procedures, including lacking an eMDR procedure and an Electronic Submissions Gateway account. Additionally, the company did not properly document the approval of numerous standard operating procedures with required signatures and dates.

## Related Documents

- [483 - 2024-03-20](https://www.globalkeysolutions.net/records/483/amco-international-manufacturing-design-inc/d31530cd-5384-400b-a763-cb6984757417)
- [WARNING_LETTER - 2024-03-20](https://www.globalkeysolutions.net/records/warning_letter/amco-international-manufacturing-design-inc/9ef2cd8f-b00a-4e21-8518-3eea107981f3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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

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