# FDA 483 - Advanced Physician Solutions, Inc. - January 16, 2015

Source: https://www.keypedia.com/records/483/advanced-physician-solutions-inc/5ad2d4e9-5d6b-4d82-8eb1-646409e4b894

> FDA 483 for Advanced Physician Solutions, Inc. on January 16, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Physician Solutions, Inc.
- Inspection Date: 2015-01-16
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection conducted at Advanced Physician Solutions, Inc. from January 12-16, 2015, identified numerous significant deficiencies in their sterile drug product manufacturing operations. The observations, detailed in an FDA Form 483, highlight critical issues related to environmental controls, aseptic processing, cleaning, and laboratory practices.Key violations included a lack of proper environmental monitoring in aseptic areas, such as missing smoke studies, unverified HEPA filtration in critical airflow, and inadequate viable air and personnel monitoring. Procedures designed to prevent microbiological contamination were found deficient, with media fill studies not accurately simulating production and insufficient documentation for sterilization processes. The firm also lacked adequate cleaning validation and disinfectant efficacy studies for its aseptic facilities.Further concerns arose from laboratory controls, which failed to include scientifically sound testing for drug product quality and purity, exemplified by incorrect sterility test incubation temperatures and the absence of endotoxin testing for sterile products. Inappropriate use of non-sterile protective apparel and container closure systems lacking leak tests were also noted. Critical equipment, including thermometers, balances, and pH meters, lacked proper calibration records, undermining product quality assurance. Additionally, the facility's operation room was compromised by the presence of food and personal items near production equipment, and drug products lacked expiration dates supported by stability data.Advanced Physician Solutions, Inc. is required to implement comprehensive corrective actions to address these observations and ensure compliance with current Good Manufacturing Practices (CGMP) as mandated by the Federal Food, Drug, and Cosmetic Act.

## Related Documents

- [WARNING_LETTER - 2015-01-16](https://www.keypedia.com/records/warning_letter/advanced-physician-solutions-inc/b443ccf4-72b3-43d3-8331-5640d885e2ed)

## Related Officers

- [Investigator](https://www.keypedia.com/people/binh-t-nguyen/14ca5620-1f92-4f5d-8663-3b63814aca26)
- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)
- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.keypedia.com/companies/advanced-physician-solutions-inc/b681589d-663b-4883-bbb6-33b2e8ff8e21

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b