FDA Warning Letter on a Drug Manufacturing Facility in South Korea
This time we focus on a drug manufacturing facility in South Korea, issued a Warning Letter on June 12, 2024
Inadequate Validation of Manufacturing Processes
The facility failed to adequately validate manufacturing processes for their over-the-counter (OTC) drug product. This includes insufficient data to demonstrate process validation and equipment qualification.
Corrective Actions
– Develop procedures for equipment qualification.
– Assess the impact of unqualified equipment on product quality.
– Establish a comprehensive validation plan for ongoing process control.
Design Deficiencies in Water System
The water system was inadequately designed, fostering biofilm development.
Corrective Actions
– Redesign to eliminate stagnant water points.
– Validate and document system modifications.
– Implement robust monitoring for water quality.
Inadequate Controls by Quality Control Unit
The quality control unit lacked oversight, leading to inadequate control over CGMP records and data integrity.
Corrective Actions
– Strengthen QU oversight for CGMP compliance.
– Improve document control procedures.
– Conduct comprehensive training on record-keeping.
Lack of Microbiological Testing
Released batches of OTC product without adequate microbiological testing.
Corrective Actions
– Implement comprehensive microbiological testing for all batches.
– Retrospective review of released batches.
– Establish clear protocols for microbial testing.
Deficiencies in Stability Testing
Lacked adequate stability data to support product shelf-life.
Corrective Actions
– Implement robust stability testing with proper conditions.
– Include representative samples in testing.
– Develop procedures for ongoing shelf-life evaluation.
Immediate Steps
- Provide a detailed response to the FDA outlining corrective actions for each violation.
- Engage a qualified CGMP consultant to perform a comprehensive audit and assist in remediation efforts.
- Halt distribution of the product until FDA approval.
These corrective actions are crucial for compliance with FDA regulations and ensure the production of safe, high-quality drug products.
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