# FDA 483 - N-Molecular Inc. d.b.a. SOFIE - May 16, 2019

Source: https://www.globalkeysolutions.net/records/483/n-molecular-inc-dba-sofie/6a7f672b-f4c8-4a52-b1fb-07347108e883

> FDA 483 for N-Molecular Inc. d.b.a. SOFIE on May 16, 2019. 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: 2019-05-16
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: N-Molecular Inc. d.b.a. SOFIE in Haverhill, MA, a sterile PET drug manufacturer, was cited for significant deficiencies during an FDA inspection from May 8-16, 2019. The firm failed to follow written quality assurance procedures, including change control for critical GMP systems and product impact assessments for temperature excursions. Additionally, essential equipment, specifically an incubator used for sterility testing, was found unsuitable for its intended purpose due to temperature control issues and ice formation, with no backup available.

## Related Documents

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- [483_RESPONSE - 2024-11-07](https://www.globalkeysolutions.net/records/483_response/n-molecular-inc-dba-sofie/106aaead-80f2-43f6-909f-2622c5f240fc)
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## Related Officers

- [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