# FDA 483 - Nostrum Laboratories Inc - April 21, 2021

Source: https://www.globalkeysolutions.net/records/483/nostrum-laboratories-inc/297a9276-a98b-46ac-a777-a80a252c0fe6

> FDA 483 for Nostrum Laboratories Inc on April 21, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nostrum Laboratories Inc
- Inspection Date: 2021-04-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Nostrum Laboratories Inc, a drug manufacturer in Kansas City, MO, revealed significant deficiencies in their quality system. The firm failed to adequately investigate product complaints for low bottle counts and did not extend investigations to other potentially affected batches. Additionally, the inspection found a systemic failure to follow written procedures for internal and external audits, vendor qualification, and corrective and preventive actions (CAPA).

## Related Officers

- [Supervisory Consumer Safety Officer](https://www.globalkeysolutions.net/people/carl-a-huffman/4fa9a65e-2aa5-417c-8369-61edab77c57f)
- [Torrey M. Ward](https://www.globalkeysolutions.net/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.globalkeysolutions.net/companies/nostrum-laboratories-inc/413bfa94-38e9-443d-a6fd-f3028c7156bf

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8