# FDA 483 - SOFIE Co - August 11, 2023

Source: https://www.globalkeysolutions.net/records/483/sofie-co/334e79a0-1b24-4651-966b-94c68e03f2e9

> FDA 483 for SOFIE Co on August 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SOFIE Co
- Inspection Date: 2023-08-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: SOFIE Co, a PET drug manufacturer in Totowa, NJ, was cited for significant quality control deficiencies during an FDA inspection. Observations included persistent microbial contamination in ISO 5 sterile manufacturing areas with inadequate corrective actions, and visible residues and corrosion in critical equipment. The firm also failed to adequately control labeling and packaging operations, leading to product mix-ups, and demonstrated deficiencies in complaint handling and out-of-specification investigations, including releasing an OOS batch for patient use.

## Related Documents

- [EIR - 2023-08-11](https://www.globalkeysolutions.net/records/eir/sofie-co/589f60cc-1dd4-42f3-8036-606b37eeca5e)

## Related Officers

- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/sofie-co/d06f8036-2bc5-4dbb-885b-341a1ecbb82a

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