# FDA 483 - Lloyd Inc. of Iowa - September 15, 2023

Source: https://www.keypedia.com/records/483/lloyd-inc-of-iowa/297e88cf-9b3b-4b48-aea8-bb7d236b46f7

> FDA 483 for Lloyd Inc. of Iowa on September 15, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lloyd Inc. of Iowa
- Inspection Date: 2023-09-15
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: Lloyd Inc., located in Shenandoah, Iowa, underwent an FDA inspection from September 11 to September 15, 2023. The inspection revealed several critical compliance issues within their manufacturing operations for human and animal drugs and food products. Key observations included inadequate maintenance of facilities, with structural damage such as rust and holes in walls and ceilings, compromising the integrity of the manufacturing environment. Additionally, the company lacked microbiological testing for Burkholderia Cepacia Complex in their cleaning processes for non-sterile products, posing a contamination risk.

The inspection also identified incomplete laboratory records and validation protocols, indicating lapses in quality control documentation. The company’s quality control procedures were found lacking, with no written responsibilities or procedures for the quality control unit, and insufficient supplier qualification processes. Furthermore, Lloyd Inc. failed to conduct necessary temperature and humidity control studies in storage areas, potentially affecting product stability.

The company’s complaint handling procedures were inadequate, as they did not ensure responses to complainants or document conclusions of investigations. Lastly, the facility was found to be undersized, leading to improper storage of materials, which could hinder effective operations.

The FDA requires Lloyd Inc. to address these violations promptly by implementing corrective actions to ensure compliance with regulatory standards. This includes repairing facility damages, establishing comprehensive microbiological testing, completing validation protocols, enhancing quality control documentation, and improving complaint handling processes. Failure to address these issues could result in further regulatory actions.

## Related Documents

- [WARNING_LETTER - 2013-04-16](https://www.keypedia.com/records/warning_letter/lloyd-inc-of-iowa/fd6bfcd6-78bb-4b8c-8444-271e85cb6d42)
- [483 - 2018-02-02](https://www.keypedia.com/records/483/lloyd-inc-of-iowa/767961d0-171c-4ab6-ae85-1791465f8a91)
- [483 - 2023-09-15](https://www.keypedia.com/records/483/lloyd-inc-of-iowa/1663122a-d7fd-41d2-b900-755814d180d6)
- [483 - 2023-09-15](https://www.keypedia.com/records/483/lloyd-inc-of-iowa/3ffe0e30-4dde-44b9-a8c1-e7e3ecb42e8f)
- [483 - 2025-11-06](https://www.keypedia.com/records/483/lloyd-inc-of-iowa/c14996fd-f746-4458-847b-2614d9379fa0)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)
- [Soyinka S. Eneng](https://www.keypedia.com/people/soyinka-s-eneng/a7f69c63-1beb-4c59-9ccd-6e35c49a10c5)

Company: https://www.keypedia.com/companies/lloyd-inc-of-iowa/b4573054-1b28-4619-88ea-c42615aede75

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79