# FDA 483 - US Specialty Formulations LLC - January 14, 2026

Source: https://www.keypedia.com/records/483/us-specialty-formulations-llc/48b75557-852b-44d0-b313-616e9c14b667

> FDA 483 for US Specialty Formulations LLC on January 14, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Specialty Formulations LLC
- Inspection Date: 2026-01-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: US Specialty Formulations LLC, an outsourcing facility in Allentown, PA, was inspected and cited for significant deficiencies across its quality control, analytical testing, stability programs, and sterile manufacturing processes. The inspection revealed a lack of scientifically sound specifications, unvalidated test methods, inadequate stability data, and failures in preventing microbiological contamination for its Sarracenia Purpurea 0.17 g/mL for Injection product. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its drug products.

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Investigator](https://www.keypedia.com/people/lu-chen/d0700911-c592-4da7-a445-5dfb2a4bedff)

Company: https://www.keypedia.com/companies/us-specialty-formulations-llc/2a5dd57a-6a0b-44a4-88ec-d642f91d1315

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8