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

Source: https://www.keypedia.com/records/483/n-molecular-inc-dba-sofie/8334bad1-3880-4c4f-be3f-cd1ee419dffb

> 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: New England District Office
- Summary: N-Molecular Inc. d.b.a. SOFIE, a sterile PET drug manufacturer in Haverhill, MA, was inspected by the FDA from May 8-16, 2019. The inspection revealed critical deviations from Good Manufacturing Practices (GMP) related to quality assurance procedures and equipment suitability.

Key violations included the firm's failure to adhere to written change control procedures. Specifically, an IT server update that impacted critical environmental control excursion notification systems for manufacturing rooms and essential equipment (like incubators) was implemented without proper change control. This oversight led to a six-month period where staff across 17 SOFIE facilities, including Haverhill, did not receive alerts for temperature and humidity excursions, a deficiency previously identified in a 2018 FDA inspection.

Additionally, the firm failed to conduct necessary product impact assessments for multiple temperature excursions in incubators used for sterility testing of PET drug products, such as 18F-Fludeoxyglucose, potentially compromising numerous batches. A critical 25°C incubator for sterility and environmental monitoring was found unsuitable due to ice formation and temperature deviations but remained in use without a backup. To address these issues, SOFIE must implement robust corrective actions, including revising and strictly following change control procedures, ensuring equipment is fit for its intended purpose, and conducting thorough product impact assessments for any deviations to comply with regulatory standards.

## Related Documents

- [EIR - 2019-05-16](https://www.keypedia.com/records/eir/n-molecular-inc-dba-sofie/3e25ed18-351f-4792-a356-58867c377891)
- [EIR - 2024-11-20](https://www.keypedia.com/records/eir/n-molecular-inc-dba-sofie/16e797e4-3b3e-4d06-ad90-150613e975ba)
- [EIR - 2018-02-28](https://www.keypedia.com/records/eir/n-molecular-inc-dba-sofie/994c8f01-6212-45e8-8111-d10b9f233511)
- [483 - 2024-11-20](https://www.keypedia.com/records/483/n-molecular-inc-dba-sofie/5083ead6-e557-4cae-b646-595f47448325)
- [483 - 2019-05-16](https://www.keypedia.com/records/483/n-molecular-inc-dba-sofie/6a7f672b-f4c8-4a52-b1fb-07347108e883)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

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