# FDA 483 - American IV Products, Inc. - September 12, 2018

Source: https://www.keypedia.com/records/483/american-iv-products-inc/a935c1d3-95b4-4499-bbb7-ab6d194a0c03

> FDA 483 for American IV Products, Inc. on September 12, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American IV Products, Inc.
- Inspection Date: 2018-09-12
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of AIV Inc, a device manufacturer in Harmanz, MD, revealed significant quality system deficiencies, many of which were repeat observations. The firm was cited for inadequate process validation, unvalidated software used in production, and insufficient procedures for design changes. Additionally, the company failed to adequately evaluate potential suppliers according to established requirements.

## Related Officers

- [Jacob M Dyer](https://www.keypedia.com/people/jacob-m-dyer/e3ca27e3-e0b1-4db8-9cbe-cfaff90b83cf)

Company: https://www.keypedia.com/companies/american-iv-products-inc/d45ab8ed-d031-4d23-bf91-ddb16bac4e93

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8