# FDA 483 - Pharmacy Innovations - November 30, 2022

Source: https://www.keypedia.com/records/483/pharmacy-innovations/b63b7d02-444f-49b0-802f-0eeed3d9218e

> FDA 483 for Pharmacy Innovations on November 30, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacy Innovations
- Inspection Date: 2022-11-30
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products, including Prostaglandin E1, Papaverine/Phentolamine, Phenol Injection, Vitamin D3, Glycerin, Prednisolone, and Testosterone injectable.

Key observations include:
- **Inadequate HEPA filter coverage and airflow:** Light pod areas in the ISO 5 laminar air flow workbench (LAFW) lack proper sealing, causing turbulent and non-unidirectional airflow. Prostaglandin E1 was prepared in areas without adequate ISO 5 HEPA coverage or unidirectional airflow.
- **Damaged/Contaminated HEPA filters:** Rust-like and yellowing discoloration was observed on multiple HEPA filters in the ISO 5 LAFW and ISO 7 anteroom.
- **Deficient Media Fill Program:** Media fills do not represent batch sizes or container types, and exclude equipment used in sterile drug product preparation (e.g., a pump for IV bag filling).
- **Inadequate Smoke Studies:** Smoke studies lacked sufficient smoke, failed to illustrate unidirectional airflow, and did not reflect all operations. Airflow was observed bouncing back from the wall.
- **Facility Design Flaws:** Doors between the non-hazardous sterile cleanroom and unclassified non-sterile laboratory were observed open simultaneously, allowing influx of poor quality air.
- **Environmental Monitoring Deficiencies:** Environmental monitoring was not performed in aseptic processing areas. Personnel monitoring procedures were flawed,

## Related Officers

- [Jazmine N. Brown](https://www.keypedia.com/people/jazmine-n-brown/194fc53f-942f-4e8c-a475-b7eac11be103)

Company: https://www.keypedia.com/companies/pharmacy-innovations/1ad5a5a8-427a-46fa-9f2e-346b6de3a27e

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