# FDA 483 - Roquette America, Inc. - June 14, 2021

Source: https://www.keypedia.com/records/483/roquette-america-inc/16ec2c36-e018-470a-93c3-f8e476204432

> FDA 483 for Roquette America, Inc. on June 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roquette America, Inc.
- Inspection Date: 2021-06-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Roquette America, Inc. in Keokuk, IA, revealed significant quality control deficiencies. The firm failed to perform resolution or system suitability for HPLC assay on Dextrose Monohydrate API finished product testing for an extended period. Additionally, there was a lack of control over the printing of in-process laboratory results by production employees.

## Related Documents

- [EIR - 2021-06-17](https://www.keypedia.com/records/eir/roquette-america-inc/534138ec-d24f-4da8-8e78-7dfc3919d6de)

## Related Officers

- [Regulatory Officer ](https://www.keypedia.com/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)
- [CDR Carl A. Huffman III](https://www.keypedia.com/people/cdr-carl-a-huffman-iii/c795e3ce-de9a-4567-9bdb-99ba9ac4731a)

Company: https://www.keypedia.com/companies/roquette-america-inc/a980f301-3e29-420c-947b-736aa8f6e5f3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8