# FDA 483 - Lohxa, LLC - July 19, 2021

Source: https://www.keypedia.com/records/483/lohxa-llc/8b860e55-417b-4f7b-9d9c-d30c9fa7fd9c

> FDA 483 for Lohxa, LLC on July 19, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lohxa, LLC
- Inspection Date: 2021-07-19
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Lohxa, LLC, a drug repacker in Worcester, MA, received four observations during an FDA inspection, with three being repeat findings. The firm was cited for significant deficiencies including a lack of validated repacking processes, use of unqualified equipment, failure to conduct annual product reviews, and incomplete batch production records. These issues indicate a systemic lack of control over critical manufacturing and quality assurance operations.

## Related Documents

- [483 - 2019-03-22](https://www.keypedia.com/records/483/lohxa-llc/f0e0080a-f100-4c33-ba93-6e6a6aad35ba)
- [483 - 2023-08-03](https://www.keypedia.com/records/483/lohxa-llc/524ebd7c-1efb-43ea-8629-57957aabb522)
- [483 - 2023-08-03](https://www.keypedia.com/records/483/lohxa-llc/2af98bd6-1800-494e-8222-3ae8958daae2)

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

Company: https://www.keypedia.com/companies/lohxa-llc/3581d621-938d-4b4f-bb9f-eb0672044836

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94