# FDA 483 - The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories - March 06, 2020

Source: https://www.globalkeysolutions.net/records/483/the-harvard-drug-group-llc-dba-major-pharmaceuticals-and-rugby-laboratories/d0271bd0-2847-4366-9b56-ec35a9cc5035

> FDA 483 for The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories on March 06, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Inspection Date: 2020-03-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The Harvard Drug Group, LLC, a corporate headquarters in Livonia, MI, was inspected and cited for significant deficiencies in its quality system. Observations included failures in drug product release testing and specifications, a dysfunctional quality control unit with inadequate procedures for supplier oversight, recall follow-up, and complaint handling, and a lack of readily available records. Additionally, the firm was found to have an insufficient number of qualified personnel for quality oversight.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [Investigator](https://www.globalkeysolutions.net/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.globalkeysolutions.net/companies/the-harvard-drug-group-llc-dba-major-pharmaceuticals-and-rugby-laboratories/c990efb6-0695-4a4b-9cad-ab3f1c365d36

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0