# FDA 483 - Glenmark Pharmaceuticals Inc  USA - July 26, 2019

Source: https://www.globalkeysolutions.net/records/483/glenmark-pharmaceuticals-inc-usa/a0d148ad-00b7-4e0e-b4b8-7335fd1e7280

> FDA 483 for Glenmark Pharmaceuticals Inc  USA on July 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenmark Pharmaceuticals Inc  USA
- Inspection Date: 2019-07-26
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Glenmark Pharmaceuticals Inc., USA in Monroe, NC, revealed a significant issue regarding the prevention of microbiological contamination in sterile drug products. The firm failed to establish procedures for the periodic re-certification of HEPA filters, which is critical for maintaining air quality in controlled environments. This deficiency could compromise the sterility of their drug products.

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Company: https://www.globalkeysolutions.net/companies/glenmark-pharmaceuticals-inc-usa/83c18d68-8e9d-454a-a365-3fe29c7d3e31

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7