# FDA 483 - Pallimed Solutions, Inc. - March 22, 2013

Source: https://www.keypedia.com/records/483/pallimed-solutions-inc/12c519ca-9d01-4350-8c48-380435e41aa9

> FDA 483 for Pallimed Solutions, Inc. on March 22, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pallimed Solutions, Inc.
- Inspection Date: 2013-03-22
- Product Type: Drugs
- Summary: The FDA Form 483 details numerous deficiencies observed during an inspection of a facility producing sterile injectable drug products.

**Facility and Operations:** The firm compounds various sterile injectable drug products, including Alprostadil, DMSO, BIMIX, Bacteriostatic Water, TRIMIX, Human Chorionic Gonadotropin (HCG), Sermorelin, and Testosterone Cypionate. Operations involve compounding, lyophilization, and aseptic filling.

**Violations and Observations:**
*   **Inadequate Investigations:** Failure to investigate the source of filamentous material and black floaters in multiple lots of sterile injectable products (e.g., Alprostadil, DMSO, BIMIX, Bacteriostatic Water, TRIMIX) observed on 03/22/2013. A prior deviation report from 12/14/2012 regarding brown floating particles in Bacteriostatic Water was not fully investigated, and the contaminated lot was not documented as rejected. Defects in lyophilized HCG (shape/color variation, lack of size uniformity) were also not investigated.
*   **Environmental Control Deficiencies:** A rip in a glove box sleeve (03/20/2013) lacked microbial ingress evaluation. Cracks and chipped paint were observed in the compounding room ceiling directly above a horizontal flow hood. Yellow/brownish discoloration was noted on the metal grid of a Laminar Flow Hood. Residue covered clear plastic curtains separating the gowning

## Related Documents

- [WARNING_LETTER - 2013-03-29](https://www.keypedia.com/records/warning_letter/pallimed-solutions-inc/7f26081d-7dc2-4ab6-a06d-0f24b773f7fe)

## Related Officers

- [Ramon E. Martinez](https://www.keypedia.com/people/ramon-e-martinez/9d3b4ce9-a11e-4c47-9e53-a5732ac13bdf)

Company: https://www.keypedia.com/companies/pallimed-solutions-inc/75bf2dc8-794a-4f1a-90e3-2f20af038774