# FDA 483 - On Site Gas Systems Inc. - March 14, 2019

Source: https://www.globalkeysolutions.net/records/483/on-site-gas-systems-inc/799a9865-4f10-4843-ab83-c1b7b0dd98db

> FDA 483 for On Site Gas Systems Inc. on March 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: On Site Gas Systems Inc.
- Inspection Date: 2019-03-14
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of On Site Gas Systems Inc. in Newington, CT, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included the absence of unique device identifiers in device history records, a lack of risk analysis for their Portable Oxygen Generator Systems, and inadequate procedures for handling and evaluating complaints for Medical Device Report (MDR) reportability. These issues indicate a need for improved compliance with medical device regulations.

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/on-site-gas-systems-inc/2506357f-69e2-48ba-842e-8f4a526b1eae

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