# FDA 483 - Matheson Tri-Gas, Inc. - April 05, 2017

Source: https://www.globalkeysolutions.net/records/483/matheson-tri-gas-inc/838d1017-f6fc-40d8-8bef-2510ba19aa5c

> FDA 483 for Matheson Tri-Gas, Inc. on April 05, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Matheson Tri-Gas, Inc.
- Inspection Date: 2017-04-05
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Matheson Tri-Gas, Inc., a medical gas manufacturer in Bangor, ME, was inspected by the FDA from April 3-5, 2017. The inspection revealed two significant issues: inadequate control of rejected drug product containers and failure of the quality control unit to follow its own procedures for reviewing calibration records. These observations indicate deficiencies in the firm's quality system.

## Related Documents

- [483 - 2017-04-05](https://www.globalkeysolutions.net/records/483/matheson-tri-gas-inc/cd5a56c3-5c7f-4927-b36a-ab30d27983e6)

## Related Officers

- [Sean R. Marcissin](https://www.globalkeysolutions.net/people/sean-r-marcissin/3cee7868-b7ea-477b-add3-218b9e7c5285)

Company: https://www.globalkeysolutions.net/companies/matheson-tri-gas-inc/363a94c6-981b-4e0d-b0ef-b21fdc10df3e

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