# FDA 483 - N-Molecular Inc. d.b.a. SOFIE - November 20, 2024

Source: https://www.globalkeysolutions.net/records/483/n-molecular-inc-dba-sofie/888f9f04-32d7-49b6-8a60-498f4f7a86f0

> FDA 483 for N-Molecular Inc. d.b.a. SOFIE on November 20, 2024. 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: 2024-11-20
- Product Type: drugs
- Office Name: New England District Office
- Summary: N-Molecular Inc. d.b.a. SOFIE in Haverhill, MA, a sterile PET drug producer, received a Form 483 with three observations. The inspection revealed significant issues including inadequate record-keeping for critical release tests, failure to follow quality assurance procedures for aseptic processing and material disinfection, and poor maintenance of equipment in critical production areas. These deficiencies indicate a high potential for product contamination and impact on drug quality.

## Related Documents

- [483 - 2018-02-28](https://www.globalkeysolutions.net/records/483/n-molecular-inc-dba-sofie/63e55155-fdc5-46fd-bc44-97f4303d19ea)
- [483 - 2019-05-16](https://www.globalkeysolutions.net/records/483/n-molecular-inc-dba-sofie/6a7f672b-f4c8-4a52-b1fb-07347108e883)
- [483_RESPONSE - 2024-11-07](https://www.globalkeysolutions.net/records/483_response/n-molecular-inc-dba-sofie/106aaead-80f2-43f6-909f-2622c5f240fc)

## Related Officers

- [James R DiOnofrio](https://www.globalkeysolutions.net/people/james-r-dionofrio/08a8b57f-4c35-4d90-8af6-81e77d4fd635)
- [James R. Birkenstamm](https://www.globalkeysolutions.net/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)
- [Deputy Director](https://www.globalkeysolutions.net/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [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/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144