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

Source: https://www.keypedia.com/records/483/n-molecular-inc-dba-sofie/b7f64cce-3592-4d35-8355-1b14c5c9666c

> 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: New England District Office
- Summary: An FDA inspection of N-Molecular Inc. d.b.a. SOFIE, a sterile PET drug manufacturer, conducted from February 12-28, 2018, identified several significant deviations from Good Manufacturing Practices. Observations included pervasive issues with facility maintenance and cleanliness, such as heavily soiled cleanroom areas, uninvestigated black stains on floors, a damaged shipping door with large gaps, and trash accumulation, including open bags of used microbiological media plates, near clean areas. The company failed to implement procedures for regular cleaning of non-classified GMP areas, a repeat observation from a previous inspection, with cleaning logs being incomplete and unreviewed by the Quality Control Unit for extended periods. Furthermore, the inspection highlighted significant deficiencies in quality assurance, including the Quality Unit's failure to review and approve a field alert report investigation for over 358 days, neglecting to conduct environmental monitoring trending or create required sampling diagrams for aseptic processing areas, and failing to review cleaning logs. Microbiological growth on environmental monitoring plates was also noted as unaddressed. Critically, a key piece of manufacturing equipment lacked a preventative maintenance program, repeatedly leading to batch failures. N-Molecular Inc. is required to implement comprehensive corrective actions to address these systemic issues, ensuring compliance with regulatory standards and safeguarding the quality and safety of its sterile PET drug products.

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- [Principal](https://www.keypedia.com/people/christopher-janik/2803fa51-5259-4632-93ad-c6f038bd2fd4)
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Company: https://www.keypedia.com/companies/n-molecular-inc-dba-sofie/25e8acb8-229e-4d63-9920-d9a698e11170

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144