# FDA 483 - Sircle Laboratories, L.L.C. - April 26, 2021

Source: https://www.keypedia.com/records/483/sircle-laboratories-llc/c921f758-7f9d-4fde-bf67-b40dfaa41925

> FDA 483 for Sircle Laboratories, L.L.C. on April 26, 2021. 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: 2021-04-26
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Sircle Laboratories, L.L.C. in Madison, MS, an own label distributor, revealed significant deficiencies in its quality control unit. The firm failed to adequately oversee contract manufacturers, approve drug product releases, and maintain proper written procedures for critical operations like batch release, vendor qualification, and change control. Several observations, including issues with quality control responsibilities and labeling procedures, were noted as repeat findings, indicating persistent compliance issues.

## Related Documents

- [483 - 2019-03-19](https://www.keypedia.com/records/483/sircle-laboratories-llc/43616b07-0547-4094-84d2-f8bbda8d877f)
- [483 - 2022-09-16](https://www.keypedia.com/records/483/sircle-laboratories-llc/56163bd0-dc8a-4e6f-b7e0-9c2f68a36e2e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

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