Warning Letter to Indian Manufacturer of Sterile Ophthalmic Drop Products

The US FDA found serious GMP violations at the facility of an Indian OTC manufacturer of sterile ophthalmic drop products. A Warning Letter has now been sent to the company.

The Indian facility is registered with the US FDA as a manufacturer of over-the-counter drugs. However, the company itself does not manufacture the ophthalmic drop products; both manufacturing and testing have been outsourced to external contractors - including quality oversight. In a written agreement, the manufacturer has also transferred responsibility for ensuring that the products comply with all regulations and GMP requirements.

The FDA now criticizes:

• Inadequate Quality Unit (quality control/assurance): According to the FDA, the Indian company does not adequately monitor quality. It has handed over important quality tasks to contract manufacturing organizations (CMOs) without adequately monitoring their processes. For example, there was a lack of control over the aseptic production of eye drops.
• Inadequate aseptic processing: aseptic processing does not meet FDA requirements. For example, the external manufacturer did not perform airflow visualization studies in order to demonstrate aseptic conditions. In addition, the CMO did not perform effectiveness testing for preservatives.

As a result, the FDA is now calling for a comprehensive plan to improve quality control and management support in order to prevent future violations, specifically:

• Strengthening the quality unit (QU): the manufacturer must ensure that the QU assumes full responsibility for all production steps and is not delegated to contractors. The QU must implement procedures and control systems that ensure compliance with GMP.
• Comprehensive review and improvement of production processes: The manufacturer must conduct a full assessment of its production processes, including aseptic conditions. This includes airflow visualizations and preservative effectiveness testing.
• Management support: Management must provide resources to proactively improve quality controls and quickly resolve production issues.

The detailed Warning Letter to the Indian ophthalmic product manufacturer is available on the FDA website.