# FDA 483 - Cyclomedica Australia Pty Ltd - August 08, 2023

Source: https://www.globalkeysolutions.net/records/483/cyclomedica-australia-pty-ltd/ee37690e-58bd-44ee-9be6-9c39df63cc31

> FDA 483 for Cyclomedica Australia Pty Ltd on August 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cyclomedica Australia Pty Ltd
- Inspection Date: 2023-08-08
- Product Type: device
- Office Name: Office of Biological Products Operations - Division I
- Summary: Cyclomedica Australia Pty Ltd received a Form 483 with four observations during an inspection of its combination drug and medical device manufacturing facility in Kingsgrove, New South Wales, Australia. The observations primarily concern deficiencies in environmental monitoring, management review attendance, release of non-conforming components, and outdated quality control documentation. These issues indicate a lack of robust quality system controls.

## Related Documents

- [483 - 2021-04-06](https://www.globalkeysolutions.net/records/483/cyclomedica-australia-pty-ltd/a21d3477-782f-4215-a4e0-ee620ce826e4)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/cyclomedica-australia-pty-ltd/408211cf-e428-4949-8f5e-b43c204b9d25)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)
- [Senior Consumer Safety Officer ](https://www.globalkeysolutions.net/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

Company: https://www.globalkeysolutions.net/companies/cyclomedica-australia-pty-ltd/1e5c064b-db2c-472e-b270-eaf65f3ae1c7

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1