Glenmark Pharma Gets USFDA Form 483 for North Carolina Site—No Data Integrity Issues Found

Glenmark Pharmaceuticals has confirmed that its Monroe, North Carolina facility was issued a Form 483 with five procedural observations following a recent inspection by the U.S. Food and Drug Administration (USFDA). The company clarified that none of the observations relate to data integrity, and all are procedural in nature.

 

Key Highlights:

 

- Inspection Timeline: Conducted by the USFDA at Glenmark’s Monroe site

- Form 483 Issued: Five observations noted, all procedural

- No Data Integrity Concerns: Company emphasized clean record on data handling

- Operational Status: The Monroe facility has not been commercializing products since August 2021

- Company Response: Glenmark is preparing a detailed corrective action plan and remains in active dialogue with the USFDA

 

The Monroe site had previously received an Official Action Indicated (OAI) classification in 2022, and Glenmark had voluntarily recalled all products from the facility. The company reiterated its commitment to quality compliance and said it is working to address the latest observations promptly.

 

While the Form 483 does not immediately impact product approvals, it signals areas where the company must improve its processes to meet USFDA expectations. Glenmark stated that it continues to cooperate fully with regulators and aims to resolve all outstanding issues at the earliest.

 

Source: CNBC-TV18, ICICIdirect, Business News Today, USFDA Inspection Records