# FDA 483 - Pharmacy Associates, Inc.  dba CompreCare Specialty Pharmacy - May 24, 2017

Source: https://www.keypedia.com/records/483/pharmacy-associates-inc-dba-comprecare-specialty-pharmacy/0c5b8adc-fc47-4a02-9630-b1b440743de0

> FDA 483 for Pharmacy Associates, Inc.  dba CompreCare Specialty Pharmacy on May 24, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacy Associates, Inc.  dba CompreCare Specialty Pharmacy
- Inspection Date: 2017-05-24
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted at Pharmacy Associates, Inc. from May 8-12 and May 24, 2017, identified nine significant observations regarding their sterile drug product manufacturing operations. The findings, documented in a Form FDA 483, highlight critical deficiencies in aseptic processing and quality control, potentially compromising product sterility. Key issues included improper handling of materials, such as an operator placing a bottle directly on a non-sterile trash can before using it in a critical aseptic area. Personnel exhibited poor aseptic technique, including improper gowning, inadequate glove disinfection, rapid movements near open sterile products, and obstruction of critical airflow in the ISO 5 laminar flow hood. Operators were observed wearing jewelry and exposing street clothing and skin during sterile operations, and non-sterile cleaning wipes and gowning components were utilized. Furthermore, the facility failed to use sporicidal agents for routine cleaning and did not perform environmental or personnel monitoring. Crucially, media fills designed to simulate aseptic production processes were inadequate, not incorporating all production equipment or worst-case conditions. Post-filtration integrity testing for sterilizing filters was also not consistently performed, raising concerns about product sterility assurance. Pharmacy Associates, Inc. is required to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices for sterile drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kenneth-e-felkley/a765e932-11df-406d-ab45-5bf4ac9ff27b)
- [Nicholas L. Paulin](https://www.keypedia.com/people/nicholas-l-paulin/a8e0649a-614f-499b-8fdc-1217f7d71887)

Company: https://www.keypedia.com/companies/pharmacy-associates-inc-dba-comprecare-specialty-pharmacy/d6b452e8-66ef-475c-9abd-321b81173adc

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa