# FDA 483 - US Specialty Formulations LLC - August 29, 2017

Source: https://www.keypedia.com/records/483/us-specialty-formulations-llc/215f8ef3-8019-43e7-865a-83813f1dd7d4

> FDA 483 for US Specialty Formulations LLC on August 29, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: US Specialty Formulations LLC
- Inspection Date: 2017-08-29
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The FDA inspection identified multiple deficiencies at the drug manufacturing facility. Personnel gowning for aseptic operations was conducted in non-classified areas without HEPA filtered air, and an employee in an ISO 5 area had exposed street clothes during Pyridoxine crimping. The cleaning procedure for aseptic areas had insufficient disinfectant contact time, lacked pre-cleaning instructions, did not specify sterile disinfectants for ISO 5 areas, and omitted recovery time after opening for cleaning; this was a repeat observation.

Equipment maintenance was deficient, with visibly rusted lower shelves on metal tables in ISO 7 and ISO 8 cleanroom areas, which contact processing materials. Drug product release testing was inadequate, as preservative content and effectiveness were not tested for Betamethasone Acetate/Sodium Phosphate sterile vials, a repeat observation for a different product.

Computer system controls were lacking: no login was required for the operating system, raw assay data files could be deleted without audit trail recording, and multiple individuals had administrator privileges. Laboratory records were deficient, lacking a second person's signature for accuracy review. Finally, container labels for outsourcing facility drug products were non-compliant, missing required information such as "This is a compounded drug," dosage form/strength, quantity/volume, inactive ingredients, and incorrect adverse event reporting information.

## Related Documents

- [483 - 2015-05-29](https://www.keypedia.com/records/483/us-specialty-formulations-llc/082792b2-03c6-4ac6-89cb-9e3cfaadffb7)
- [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)

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