# FDA 483 - Medical Technical Gases, Inc. - October 12, 2023

Source: https://www.keypedia.com/records/483/medical-technical-gases-inc/c50ac000-f3ca-4b45-bbe6-190e61759ded

> FDA 483 for Medical Technical Gases, Inc. on October 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Technical Gases, Inc.
- Inspection Date: 2023-10-12
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Medical Technical Gases, Inc. in N Billerica, MA, a medical gas manufacturer, revealed significant deficiencies in quality control unit procedures and batch production records. The firm failed to properly follow labeling verification and nitrogen identity testing procedures, and did not control the issuance of medical fill logs. These issues, including repeat observations from a previous inspection, indicate a concerning lack of adherence to established quality and documentation practices.

## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

Company: https://www.keypedia.com/companies/medical-technical-gases-inc/80fbef0a-1ee3-4788-8291-1a9e0b74ca56

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