# FDA 483 - Pharmedium Services, LLC - March 22, 2013

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/a5958d62-7345-46f0-a7b6-97eaa24a42fb

> FDA 483 for Pharmedium Services, LLC on March 22, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmedium Services, LLC
- Inspection Date: 2013-03-22
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection conducted from March 18-22, 2013, at PharMEDium Services, LLC. in Memphis, TN, identified twelve significant objectionable conditions, indicating systemic failures in adhering to Good Manufacturing Practices for injectable drug products. Key issues included widespread non-adherence to written production and process control procedures, particularly concerning aseptic technique, personnel gowning, and sanitization within laminar airflow hoods. The facility also exhibited an inadequate air filtration system, lacking proper documentation for airflow studies and HEPA filter integrity. Procedures to prevent microbiological contamination were insufficient, with no final filtration step for sterile products, improper sanitization of packaging components, and incomplete facial covering requirements for personnel in aseptic areas. Laboratory controls were deemed deficient, with scientifically unsound potency limits, absence of growth promotion testing for microbiological media, and lack of specific environmental monitoring locations. Furthermore, the company failed to conduct endotoxin testing on finished sterile injectable products and lacked adequate validation of its sterilization processes, as media fills did not simulate the entire manufacturing process. There was a critical absence of finished product potency and sterility testing for each lot, with only annual, random testing performed. The stability program was insufficient, lacking sterility and impurity testing, and container/closure testing relied on unvalidated supplier data, contributing to product complaints. The Quality Control unit demonstrated a lack of authority by failing to detect and address significant temperature excursions in incubators. Component storage was inadequate, and the firm did not retain reserve drug product samples. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, necessitate prompt corrective actions to ensure product quality and patient safety.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
- [Investigator](https://www.keypedia.com/people/dell-s-moller/d089577b-e30c-4f44-9b52-463cf38bbd68)

Company: https://www.keypedia.com/companies/pharmedium-services-llc/9b6f5bdb-3f56-46d7-8dce-984393afb298

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea