# FDA 483 - N-Molecular Inc. d.b.a. SOFIE - February 28, 2018

Source: https://www.globalkeysolutions.net/records/483/n-molecular-inc-dba-sofie/63e55155-fdc5-46fd-bc44-97f4303d19ea

> FDA 483 for N-Molecular Inc. d.b.a. SOFIE on February 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: N-Molecular Inc. d.b.a. SOFIE
- Inspection Date: 2018-02-28
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: M-Molecular Inc. d.b.a. SOFIE in Haverhill, MA, a sterile PET drug manufacturer, received a Form 483 with six observations. The inspection revealed significant deficiencies in equipment suitability and maintenance, production and process controls for aseptic manufacturing, facility contamination prevention, and adherence to quality assurance procedures. These issues indicate a lack of robust controls to ensure product quality and sterility.

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## Related Officers

- [Principal](https://www.globalkeysolutions.net/people/christopher-janik/2803fa51-5259-4632-93ad-c6f038bd2fd4)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.globalkeysolutions.net/companies/n-molecular-inc-dba-sofie/25e8acb8-229e-4d63-9920-d9a698e11170

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