# FDA 483 - PharMEDium Services LLC - February 28, 2013

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/06dda9c7-6e5f-4a1b-b7da-fa1b1646d281

> FDA 483 for PharMEDium Services LLC on February 28, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PharMEDium Services LLC
- Inspection Date: 2013-02-28
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in the facility's quality systems and manufacturing processes for sterile drug products.

**Personnel and Gowning:**
Observation 1 notes that personnel clothing is inappropriate for sterile drug processing. Operators touch sterile gowns with bare hands during gowning (per procedure CPS-305, 11/30/2012), and gowns are re-used and re-handled during cleanroom exit/re-entry, potentially compromising sterility.

**Laboratory System Deficiencies:**
*   **Sterility and Endotoxin Testing (Observation 2):** Batches of sterile drug products are not adequately tested for sterility and pyrogen-free requirements. Only 52 of 2012's sterile drug lots were sterility tested, and no endotoxin testing data exists for any sterile drug lots produced from January 2012 to the present.
*   **Identity and Strength Testing (Observation 3):** Routine identification and potency testing is not performed on most of the firm's 30+ sterile drug products. In 2012, only 12.7% of lots were tested, with 99.3% of that testing restricted to Magnesium Sulfate and Oxytocin.
*   **Expiration Date Determination (Observation 4):** Expiration dates are not based on site-specific processing conditions. All expiration dates, such as 9

## Related Documents

- [483 - 2017-12-13](https://www.keypedia.com/records/483/pharmedium-services-llc/6c75fb6b-687d-4e76-a3dc-ffa29587fa53)

Company: https://www.keypedia.com/companies/pharmedium-services-llc/d6b93694-93ea-4852-b10b-06e30501e380

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c