# FDA 483 - Jost Chemical Co. - October 13, 2023

Source: https://www.keypedia.com/records/483/jost-chemical-co/a56d9c5b-a61e-42c1-ac25-2a4b0fa1419b

> FDA 483 for Jost Chemical Co. on October 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jost Chemical Co.
- Inspection Date: 2023-10-13
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted from October 10-13, 2023, at an Active Pharmaceutical Ingredient (API) manufacturing facility in Saint Louis, MO, resulted in the issuance of a Form 483, detailing significant observations. This report, issued under the Federal Food, Drug, and Cosmetic Act, highlights two primary areas of concern.

Firstly, the facility was cited for inadequate written records and follow-up in investigating critical deviations and product failures. A specific instance involved Zinc Citrate Dihydrate USP, which failed microbial specifications (190 CFUs/g exceeding the limit) due to Aspergillus flavus/oryzae contamination. An investigation was initiated, but a root cause was not established, and the contaminated batch, manufactured in September 2022, was not fully recovered from the customer, indicating a delayed and incomplete response to a significant quality issue.

Secondly, observations revealed deficiencies in equipment design and cleaning practices. Specifically, equipment on two production lines exhibited air gaps that allowed direct ingress of contaminants from the external production environment into product contact areas. This raises concerns about the purity and safety of products manufactured on these lines, including Potassium Nitrate USP and Sodium Phosphate Monobasic Monohydrate USP.

These observations signify practices that require immediate corrective action from the manufacturer to ensure product quality and adherence to regulatory standards for pharmaceutical ingredients. The company is expected to provide a detailed response addressing how these issues will be remedied to achieve compliance.

## Related Documents

- [EIR - 2018-01-18](https://www.keypedia.com/records/eir/jost-chemical-co/9ea6bda6-539b-4bde-9661-0c1a4d37b782)
- [483 - 2022-01-21](https://www.keypedia.com/records/483/jost-chemical-co/9bbf1ada-882a-4177-bc6d-8be98a682a5f)
- [WARNING_LETTER - 2022-01-21](https://www.keypedia.com/records/warning_letter/jost-chemical-co/50823051-5eea-4a38-9e05-ba53d95d4192)
- [EIR - 2023-10-13](https://www.keypedia.com/records/eir/jost-chemical-co/95eddc80-4057-4f06-9470-bc0937393d44)
- [483 - 2023-10-13](https://www.keypedia.com/records/483/jost-chemical-co/ba327131-47b9-4bb0-be86-4d850eec19a1)

## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/jost-chemical-co/42828577-321c-4fe1-a2b7-ec1df451cd8e

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516