# FDA 483 - US Specialty Formulations LLC - March 26, 2025

Source: https://www.globalkeysolutions.net/records/483/us-specialty-formulations-llc/a05165b7-ed9d-4680-b279-3e464026ec25

> FDA 483 for US Specialty Formulations LLC on March 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Specialty Formulations LLC
- Inspection Date: 2025-03-26
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: US Specialty Formulations LLC, an Allentown, PA manufacturer, was cited for significant deficiencies in its production, laboratory, and quality control processes during an FDA inspection. The observations highlight a lack of validation for manufacturing processes, analytical methods, and cleaning procedures, particularly concerning Sarracenia Purpurea Bulk Distillate. Additionally, the firm failed to adequately test components and maintain proper written procedures for its quality control unit.

## Related Documents

- [483 - 2022-04-26](https://www.globalkeysolutions.net/records/483/us-specialty-formulations-llc/2ff0d13c-a3ce-40eb-ad34-b5b1e999f613)
- [483 - 2024-07-02](https://www.globalkeysolutions.net/records/483/us-specialty-formulations-llc/02180e72-25a9-4bdf-970c-9567cf7a7ce8)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/us-specialty-formulations-llc/4dd416c3-7118-437a-bcb5-8ca83ae76b15)
- [483 - 2026-01-14](https://www.globalkeysolutions.net/records/483/us-specialty-formulations-llc/48b75557-852b-44d0-b313-616e9c14b667)

## Related Officers

- [Rabinah Anatullah](https://www.globalkeysolutions.net/people/rabinah-anatullah/ec3a3855-2e6c-460f-827c-16fe0f406635)
- [Investigator](https://www.globalkeysolutions.net/people/lu-chen/d0700911-c592-4da7-a445-5dfb2a4bedff)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)

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

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