# FDA 483 - Aucta Pharmaceuticals, Inc. - October 03, 2025

Source: https://www.globalkeysolutions.net/records/483/aucta-pharmaceuticals-inc/04b2586e-46db-4320-ad8e-9157e80e719a

> FDA 483 for Aucta Pharmaceuticals, Inc. on October 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aucta Pharmaceuticals, Inc.
- Inspection Date: 2025-10-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Aucta Pharmaceuticals, Inc. in Piscataway, NJ, revealed a significant deviation from written production and process control procedures. The firm failed to conduct a required performance qualification study for a mixer used in the manufacturing of a drug product, (b) (4) Oral Suspension. This indicates a lapse in equipment validation and adherence to internal quality management plans.

## Related Documents

- [483 - 2023-06-07](https://www.globalkeysolutions.net/records/483/aucta-pharmaceuticals-inc/6846d5a2-500d-44dd-8374-01a2db918d33)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.globalkeysolutions.net/companies/aucta-pharmaceuticals-inc/5009424c-bfc8-43a9-957b-301b0ea9fe84

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