# FDA 483 - Argenta US Manufacturing LLC - December 14, 2022

Source: https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/9beed67d-18ad-459e-8475-e3e1cd432072

> FDA 483 for Argenta US Manufacturing LLC on December 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Argenta US Manufacturing LLC
- Inspection Date: 2022-12-14
- Product Type: drugs
- Office Name: Office of Compliance Intervention and Consultation
- Summary: During an FDA inspection conducted at TriRx Shawnee, LLC between December 5 and 14, 2022, several significant compliance deficiencies were observed, as documented in an FDA Form 483. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act, particularly regarding good manufacturing practices for animal and human drug products.A primary concern was the inadequate investigation of unexplained discrepancies and out-of-specification results. For instance, stability texture analysis results for a tablet product, initially outside specifications, were dismissed after repeat testing without a clear root cause identification. Furthermore, a critical customer complaint investigation lacked thorough documentation and a justifiable rationale for managing retention samples.Another key issue involved the insufficient procedures for preventing microbiological contamination in sterile drug manufacturing. Interventions performed during media fills did not accurately represent routine production and lacked scientific justification, with no consistent tracking of intervention types or frequencies.Lastly, the inspection highlighted serious deficiencies in component testing. TriRx Shawnee used a raw material, (b)(4), in parenteral drug production without conducting customer-required endotoxin testing or verifying its specified percentage. Disturbingly, multiple lots of this material, explicitly labeled by the supplier as "Not Intended for Parenteral Use," were nevertheless coded and utilized for parenteral drug manufacturing. The company is now required to address these findings through comprehensive corrective actions.

## Related Documents

- [483 - 2019-08-01](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/cc66e0cd-37b1-4ff2-8e3b-643c76b103a1)
- [EIR - 2019-08-01](https://www.keypedia.com/records/eir/argenta-us-manufacturing-llc/3c751856-4cce-47be-bcc2-0188ed0805c5)
- [483 - 2022-12-14](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/6f50f0bb-ae80-47bc-aeea-32adbf0905ad)
- [483 - 2023-12-15](https://www.keypedia.com/records/483/argenta-us-manufacturing-llc/51884969-1aac-44e5-8e42-db0251a23cbd)

## Related Officers

- [Mark L. Baum](https://www.keypedia.com/people/mark-l-baum/03c8bd98-912b-43f9-9e41-6ffb00bc3cfe)
- [Phillip C. Trefsgar](https://www.keypedia.com/people/phillip-c-trefsgar/8034282c-6b16-46e7-9a56-dbe32e0b99dd)

Company: https://www.keypedia.com/companies/argenta-us-manufacturing-llc/be369a5c-ac21-4111-897f-1f4983ce11bc

Office: https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54