# FDA 483 - SOFIE Co. dba SOFIE - April 21, 2022

Source: https://www.keypedia.com/records/483/sofie-co-dba-sofie/45223af2-ae88-434e-9b7e-021fac6ff368

> FDA 483 for SOFIE Co. dba SOFIE on April 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SOFIE Co. dba SOFIE
- Inspection Date: 2022-04-21
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: SOFIE Co. dba SOFIE, a PET drug manufacturer in Morgantown, WV, was cited for failing to implement adequate procedures to ensure equipment suitability for its intended purposes. The inspection revealed deficiencies including a lack of light intensity verification for drug product inspection and the absence of written preventive maintenance programs for manufacturing equipment and aseptic manipulation units, which could adversely affect drug quality.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.keypedia.com/companies/sofie-co-dba-sofie/c683c431-3e42-49e6-a2fa-20743b596202

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248