# FDA 483 - Stanley Specialty Pharmacy Compounding and Wellness Center - July 07, 2016

Source: https://www.keypedia.com/records/483/stanley-specialty-pharmacy-compounding-and-wellness-center/ef328bd0-ca3e-48a6-b431-0e418267d1a0

> FDA 483 for Stanley Specialty Pharmacy Compounding and Wellness Center on July 07, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stanley Specialty Pharmacy Compounding and Wellness Center
- Inspection Date: 2016-07-07
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: Stanley Specialty Pharmacy Compounding and Wellness Center received an FDA Form 483 following an inspection conducted from June 6 to July 7, 2016. The inspection revealed several significant observations related to the firm's sterile drug production processes, indicating a need for improved quality control and adherence to established manufacturing standards.

Key observations included a deficient system for monitoring environmental conditions within aseptic processing areas. The firm was found not to conduct environmental or personnel monitoring during or after sterile operations, and viable surface monitoring was performed infrequently. Additionally, protective apparel worn by employees was inadequate, with operators exhibiting exposed skin on their neck, face, and forehead while working in critical ISO 5 laminar air flow hoods, and sterile gowning was not utilized.

The FDA also noted that procedures intended to prevent microbiological contamination of sterile drug products lacked validation of the sterilization process. Specifically, media fills did not accurately simulate actual production or incorporate the most challenging conditions to ensure reproducibility and prevent contamination. Furthermore, the cleaning and disinfection system for aseptic processing areas was found deficient, as the firm used a sporicidal agent without scientific data to support its concentration and contact time for effective disinfection.

These observations highlight areas where the company needs to implement corrective actions to ensure the safety, quality, and sterility of its drug products, aligning its practices with appropriate manufacturing guidelines. The firm is expected to address these findings to demonstrate compliance with regulatory expectations for sterile drug production.

## Related Documents

- [483 - 2017-08-04](https://www.keypedia.com/records/483/stanley-specialty-pharmacy-compounding-and-wellness-center/211add79-8d3c-4a62-8a47-8b3105b00d63)
- [483 - 2021-10-01](https://www.keypedia.com/records/483/stanley-specialty-pharmacy-compounding-and-wellness-center/b2cad1c9-8eda-43b5-88e6-f222df4c5e3c)

## Related Officers

- [Director of Inspection Readiness](https://www.keypedia.com/people/bonita-s-chester/cc6ce6f4-bb5c-452a-820c-3339361bc8b2)

Company: https://www.keypedia.com/companies/stanley-specialty-pharmacy-compounding-and-wellness-center/166cf1bf-afc6-4500-833e-36ecfb5b7c1a

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7