# FDA 483 - InfuTronix LLC - August 16, 2023

Source: https://www.globalkeysolutions.net/records/483/infutronix-llc/62ea8c06-5a56-4145-82a7-f600dae800aa

> FDA 483 for InfuTronix LLC on August 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InfuTronix LLC
- Inspection Date: 2023-08-16
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: InfuTronix LLC, a medical device manufacturer in Natick, MA, received a Form 483 with four repeat observations highlighting significant quality system deficiencies. The firm failed to adequately establish corrective and preventive action procedures, investigate device complaints in a timely manner, and submit Medical Device Reports within the required 30 days. Additionally, management did not conduct regular reviews of the quality system.

## Related Documents

- [483 - 2022-02-15](https://www.globalkeysolutions.net/records/483/infutronix-llc/580867b3-ced1-4f14-a028-ca5158c83a57)
- [WARNING_LETTER - 2022-02-15](https://www.globalkeysolutions.net/records/warning_letter/infutronix-llc/e5df945b-61ed-444f-980d-415f93daeb0f)

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/infutronix-llc/edcd86cd-cf3f-4eef-a9ab-f5e2dc793a73

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7