# Nippon Sanso Matheson, Inc. – FDA 483, Apr 5, 2017

Source: https://www.keypedia.com/records/483/nippon-sanso-matheson-inc/838d1017-f6fc-40d8-8bef-2510ba19aa5c

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

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## Details

- Record Type: 483
- Company Name: Nippon Sanso Matheson, Inc.
- Inspection Date: 2017-04-05
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- 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 Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Site Manager](https://www.keypedia.com/people/jeffrey-h-neubauer/77396e64-c1f2-4a47-8b9f-345443f85bd4)

Company: https://www.keypedia.com/companies/nippon-sanso-matheson-inc/363a94c6-981b-4e0d-b0ef-b21fdc10df3e

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94