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

Source: https://www.keypedia.com/records/483/lloyd-inc-of-iowa/3ffe0e30-4dde-44b9-a8c1-e7e3ecb42e8f

> 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: Department of Health and Human Services
- Summary: On September 11-15, 2023, FDA investigators Soyinka S. Eneng and Michele Perry-Williams inspected Lloyd Inc., of Iowa, a manufacturer of human and animal drugs and animal food products located at 604 W Thomas Ave, Shenandoah, IA. The inspection revealed seven observations.

Observation 1 noted that buildings used for holding drug products were not maintained in good repair. Specific issues included residue on laboratory walls, rust on a sink near the (b)(4) Processing area, rust stains on a ceiling pipe above the (b)(4) Processing area, and numerous holes/openings around dock doors in both the manufacturing/packaging and warehouse facilities, as well as holes in the ceiling over label/labels used during packaging.

Observation 2 indicated that procedures to prevent objectionable microorganisms in non-sterile drug products were not established, specifically lacking microbiological testing for Burkholderia Cepacia Complex in USP water used for cleaning processing equipment.

Observation 3 stated that laboratory records lacked complete documentation of testing and standardization of reference standards and solutions. Analytical work under Protocols VAP-02-2015 and VAP-04-2016 was not fully validated or documented in a validation report, and CAPA Effectiveness Check No. EC-001-2020 lacked a target completion date.

Observation 4 found that responsibilities and procedures for the quality control unit were not in writing. Supplier

## 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/297e88cf-9b3b-4b48-aea8-bb7d236b46f7)
- [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/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861