# FDA 483 - ChemPacific Corporation - February 15, 2024

Source: https://www.keypedia.com/records/483/chempacific-corporation/d11383fd-a74c-4e91-be85-ed5a06098984

> FDA 483 for ChemPacific Corporation on February 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ChemPacific Corporation
- Inspection Date: 2024-02-15
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of ChemPacific Corporation in Baltimore, MD, an Active Pharmaceutical Ingredient manufacturer, revealed significant deficiencies in their quality control unit and manufacturing processes. The firm failed to thoroughly investigate out-of-specification and out-of-trend results for Norepinephrine Bitartrate, released product with microbiological contamination, and maintained unsanitary facility conditions. Additionally, issues were noted with incomplete batch production records, inadequate cleaning procedures, and a lack of qualified equipment for environmental control.

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [Azeezat M. Lawal](https://www.keypedia.com/people/azeezat-m-lawal/6068345c-a8c8-438e-9b59-f7fc35370a59)

Company: https://www.keypedia.com/companies/chempacific-corporation/193b1f68-27d2-4a77-af09-995fc39a7c20

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64