# FDA 483 - Speciality Pharma Manufacturing, LLC - April 08, 2025

Source: https://www.globalkeysolutions.net/records/483/speciality-pharma-manufacturing-llc/6a9b58bf-858d-4d53-b600-79fac25debd0

> FDA 483 for Speciality Pharma Manufacturing, LLC on April 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Speciality Pharma Manufacturing, LLC
- Inspection Date: 2025-04-08
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Speciality Pharma Manufacturing, LLC in Carlstadt, NJ, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to adequately test finished drug products and raw materials, establish proper process and cleaning validations, and maintain appropriate equipment qualification and stability assessments. These issues indicate a systemic lack of control over drug product identity, strength, purity, and quality.

## Related Documents

- [483 - 2020-03-16](https://www.globalkeysolutions.net/records/483/speciality-pharma-manufacturing-llc/2ea3b49a-91cd-46e7-a8f7-c7e094d4aee8)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)

Company: https://www.globalkeysolutions.net/companies/speciality-pharma-manufacturing-llc/afeaf00e-9366-48fe-a7f1-65891c3588d0

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