# FDA 483 - Warner Graham LLLP - May 21, 2024

Source: https://www.globalkeysolutions.net/records/483/warner-graham-lllp/7ad5a978-d681-490a-9958-d7426e8d89c6

> FDA 483 for Warner Graham LLLP on May 21, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Warner Graham LLLP
- Inspection Date: 2024-05-21
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Warner Graham LLLP in Cockeysville, MD, a repacker and manufacturer, revealed significant deficiencies across its operations. The firm failed to establish adequate production and process controls, quality control unit procedures, and equipment cleaning protocols. Additionally, issues were noted with microorganism prevention, master production records, and the absence of a stability testing program for drug products.

## Related Documents

- [483 - 2016-09-09](https://www.globalkeysolutions.net/records/483/warner-graham-lllp/b958555a-4003-411e-98a3-2d5883c312b1)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/warner-graham-lllp/b7f7ddcd-3aa8-4189-8732-9a854956ce5f

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