# FDA 483 - Neilmed Pharmaceuticals Inc - December 02, 2022

Source: https://www.globalkeysolutions.net/records/483/neilmed-pharmaceuticals-inc/9d5ee954-9116-4e0f-8ba7-7ca4eb469a45

> FDA 483 for Neilmed Pharmaceuticals Inc on December 02, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Neilmed Pharmaceuticals Inc
- Inspection Date: 2022-12-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Neilmed Pharmaceuticals Inc. in Santa Rosa, CA, a drug manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included a lack of a functional quality control unit, inadequate complaint investigations, improper equipment cleaning and verification, and insufficient testing of raw materials and finished drug products. The firm also failed to document production deviations and ensure proper storage conditions for materials.

## Related Officers

- [Dogbeda F. Mackenzie](https://www.globalkeysolutions.net/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.globalkeysolutions.net/companies/neilmed-pharmaceuticals-inc/3900fd37-ad3b-4497-a182-db1d1b74f443

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b