# FDA 483 - N-Molecular, Inc. dba SOFIE - January 13, 2020

Source: https://www.keypedia.com/records/483/n-molecular-inc-dba-sofie/81a5c5d1-39a2-4215-8d0a-e9f50174e667

> FDA 483 for N-Molecular, Inc. dba SOFIE on January 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: N-Molecular, Inc. dba SOFIE
- Inspection Date: 2020-01-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of M-Molecular, Inc. dba SOFIE, a PET drug manufacturer in Colonie, NY, revealed significant deficiencies in quality control and personnel training. Observations included a failure to verify an established analytical test procedure for Fludeoxyglucose F-18 (FDG) release testing. Additionally, the firm did not implement adequate corrective actions for recurring out-of-specification results caused by poor laboratory practices and lacked necessary GMP training records for manufacturing personnel.

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.keypedia.com/companies/n-molecular-inc-dba-sofie/174feca7-eb92-4be2-a81d-4f7c2697b112

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961