# FDA 483 - US Specialty Formulations LLC - May 29, 2015

Source: https://www.keypedia.com/records/483/us-specialty-formulations-llc/082792b2-03c6-4ac6-89cb-9e3cfaadffb7

> FDA 483 for US Specialty Formulations LLC on May 29, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Specialty Formulations LLC
- Inspection Date: 2015-05-29
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 details observations from an inspection, indicating significant deficiencies in a drug manufacturing facility, particularly concerning sterile drug production.

**Key Observations:**

*   **Quality System Deficiencies:**
    *   Investigations into unexplained discrepancies are not consistently documented.
    *   Time limits for production phases are not established.
*   **Aseptic Processing & Environmental Control:**
    *   Environmental monitoring systems in aseptic processing areas are deficient.
    *   Cleaning and disinfection systems for aseptic areas and equipment are inadequate.
    *   Protective apparel is not consistently worn to prevent drug product contamination.
*   **Sterilization & Contamination Control:**
    *   Procedures to prevent microbiological contamination of sterile drug products are not established or adequately validated.
    *   Sterilization processes lack adequate validation.
    *   Each batch of sterile and pyrogen-free drug product is not laboratory tested for conformance.
*   **Facility & Equipment:**
    *   Building location is unsuitable for cleaning, maintenance, and proper operations.
    *   Equipment and utensils are not cleaned and maintained at appropriate intervals, risking contamination and malfunction.
*   **Product Release & Labeling:**
    *   Drug products are not always tested for conformance to final specifications prior to release.
    *   Drug product labels do not consistently contain information required by section 503B(a)(10)(A) and (B) of

## Related Documents

- [483 - 2017-08-29](https://www.keypedia.com/records/483/us-specialty-formulations-llc/215f8ef3-8019-43e7-865a-83813f1dd7d4)
- [483 - 2019-07-23](https://www.keypedia.com/records/483/us-specialty-formulations-llc/ebc65180-dc73-40c9-a085-9b4c9dc703b0)

## Related Officers

- [James M. Mason](https://www.keypedia.com/people/james-m-mason/a9f601a9-5d81-4386-90dc-80466edb5880)
- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/us-specialty-formulations-llc/879d3e11-8ddf-429d-b58d-6b2a8bff37ce

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