# FDA 483 - Sircle Laboratories, L.L.C. - September 16, 2022

Source: https://www.keypedia.com/records/483/sircle-laboratories-llc/56163bd0-dc8a-4e6f-b7e0-9c2f68a36e2e

> FDA 483 for Sircle Laboratories, L.L.C. on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sircle Laboratories, L.L.C.
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Sircle Laboratories, L.L.C., an Own Label Distributor in Madison, MS, was inspected and cited for significant deficiencies in its quality control unit, personnel training, and record-keeping practices. The inspection revealed a systemic lack of written procedures and failure to follow existing ones, particularly concerning quality unit responsibilities, document control, vendor qualification, and employee training. These issues indicate a fundamental breakdown in the firm's adherence to current Good Manufacturing Practices.

## Related Documents

- [483 - 2019-03-19](https://www.keypedia.com/records/483/sircle-laboratories-llc/43616b07-0547-4094-84d2-f8bbda8d877f)
- [483 - 2021-04-26](https://www.keypedia.com/records/483/sircle-laboratories-llc/c921f758-7f9d-4fde-bf67-b40dfaa41925)

## Related Officers

- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.keypedia.com/companies/sircle-laboratories-llc/b5a76d52-ab2d-42aa-ac2f-012952d6e6b4

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea