# FDA 483 - Pharmedium Services, LLC - September 24, 2015

Source: https://www.keypedia.com/records/483/pharmedium-services-llc/0e5b3c76-f017-4c17-a923-5d6931489802

> FDA 483 for Pharmedium Services, LLC on September 24, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmedium Services, LLC
- Inspection Date: 2015-09-24
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details multiple deficiencies at a drug product manufacturing facility.

**Facility and Operations:** The firm produces sterile drug products, including Norepinephrine, Magnesium Sulfate, Vancomycin HCl, and Oxytocin.

**Violations and Observations:**
1.  **Aseptic Technique Failure:** On 08/24/2015, a pharmacist placed their head inside an ISO 5 Laminar Air Flow hood while collecting Norepinephrine 4mg 250 ml, 5% Dextrose Injection, USP (Lot 15236112S), violating SOP CPS-305, Version 13.0, which prohibits leaning into or against the hood.
2.  **Deficient Sterility and Endotoxin Testing:** The firm failed to perform sterility and endotoxin testing on each lot of sterile drug product prior to release and distribution, only testing a fraction of products. Examples include Norepinephrine (Lot 15236112S), Magnesium Sulfate (Lot 15237091S), Vancomycin HCl (Lot 15238397S), and Oxytocin (Lot 15237111S), all shipped prior to sterility testing.
3.  **Deficient Potency Testing:** Potency testing was not performed on each lot of drug product prior to release and distribution, only on a fraction

## Related Documents

- [483 - 2015-07-16](https://www.keypedia.com/records/483/pharmedium-services-llc/e84e5ade-6469-4a83-9821-3344f6faba73)
- [483 - 2015-07-13](https://www.keypedia.com/records/483/pharmedium-services-llc/508b5cb2-c535-4f24-8c66-413ec0a53090)
- [483 - 2016-01-04](https://www.keypedia.com/records/483/pharmedium-services-llc/e7b67d64-4cfd-4b7d-8e22-de4ecc8e422e)
- [483 - 2016-05-26](https://www.keypedia.com/records/483/pharmedium-services-llc/be691387-003c-427d-bd91-6ef709f07b92)
- [483 - 2013-02-27](https://www.keypedia.com/records/483/pharmedium-services-llc/e18039f2-fd62-422b-b61b-7ab2df91126c)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)
- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)
- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9