Exploring Arsen Karapetyan’s FDA Activity for Proactive Compliance

When it comes to FDA inspections, Arsen Karapetyan, a Consumer Safety Officer based in Long Beach, California, has built a reputation for his thorough inspections and ability to identify critical compliance issues. 

With over 630 inspections and more than 120 Form 483s issued, Karapetyan has provided invaluable insights into the most common compliance pitfalls in the pharmaceutical and biotech industries. 

This blog takes a deeper look at Karapetyan’s inspection profile, highlighting the areas of focus in his reports and how manufacturers can use this information to stay compliant and reduce the risk of violations.

The Role of Arsen Karapetyan in FDA Inspections

Arsen Karapetyan is an experienced FDA investigator responsible for conducting inspections across various industries, with a strong emphasis on pharmaceutical manufacturing, biotech products, and medical device production. 

His primary role involves evaluating companies’ compliance with FDA regulations, like Good Manufacturing Practices (GMP), labeling standards, and product safety. By identifying gaps and deficiencies, Karapetyan helps manufacturers avoid regulatory fines and legal challenges.

Key Stats on Arsen Karapetyan’s Inspections:

• Total Inspections: 630
• Form 483s Issued: 122
• Warning Letters Issued: 17
• Longest Inspection: 71 days
• Shortest Inspection: 1 day
• Average Length of Inspection: 5.4 days

Key Areas FDA Inspectors Focus on During Inspections

FDA inspectors like Arsen Karapetyan focus on several crucial areas during inspections to ensure that manufacturers adhere to regulatory standards. These key focus points include:

1. Product Safety and Handling: Inspectors assess the safety of products throughout their lifecycle, from storage and transportation to handling and distribution, ensuring that proper precautions are taken to prevent contamination or damage.
2. Sanitation and Hygiene Practices: Ensuring that facilities meet cleanliness and hygiene standards is critical in preventing contamination and ensuring product safety. Inspectors evaluate whether proper sanitation procedures are in place and being followed.
3. Labeling and Packaging: Inspectors verify that product labeling and packaging comply with FDA regulations. This includes checking ingredient lists, dosage instructions, and safety warnings to ensure consumers receive accurate information.
4. Quality Control Systems: A major area of focus during inspections is the effectiveness of a company’s quality control systems. Inspectors evaluate whether products undergo adequate testing, whether raw materials meet safety standards, and whether final products are thoroughly reviewed before release.
5. Documentation and Record Keeping: Inspectors ensure that accurate and complete production records are maintained. This documentation is vital for traceability in case of recalls, future inspections, or compliance verification.

Top Compliance Issues Identified by Arsen Karapetyan

Over his extensive career, Karapetyan has identified several recurring compliance issues that companies in the pharma and biotech sectors must address to ensure they are FDA-compliant. These issues often appear in Form 483s issued during inspections and can lead to regulatory consequences if not corrected.

1. Non-Compliance with GMP Guidelines

One of the most common findings in Karapetyan’s inspections is non-compliance with Good Manufacturing Practices (GMP). GMP ensures that products are consistently produced and controlled according to strict quality standards. Violations of GMP guidelines, like improper sanitation, unqualified personnel, or incorrect documentation, can result in contaminated products and major compliance risks.

Tip for Compliance: Ensure thorough employee training on GMP standards and implement regular internal audits to identify potential gaps. Consistent attention to facility hygiene and maintenance is crucial for compliance.

2. Inadequate Documentation Practices

During inspections, Karapetyan often finds companies lacking sufficient or accurate documentation for their production processes. Proper record-keeping is vital for tracking product quality and for transparency in the event of a recall or inspection. Inadequate documentation can make it impossible to trace a product’s origin, leading to non-compliance findings.

Tip for Compliance: Implement a reliable documentation system that tracks every stage of production, from raw materials to finished goods. Ensure that all records are complete, accurate, and readily accessible during inspections.

3. Deficient Quality Control Systems

Karapetyan frequently observes deficiencies in quality control (QC) systems, which are essential for ensuring product consistency and safety. Inadequate QC measures may include improper testing of raw materials, failure to check batch samples, or an incomplete review of final products before they hit the market.

Tip for Compliance: Build a robust QC system that involves multiple checkpoints during the production process. Regularly test raw materials and final products, and ensure that testing equipment is calibrated and in good working order.

4. Failure to Address Corrective Actions Promptly

One of the biggest challenges revealed in Karapetyan’s inspections is the delay in implementing corrective actions for identified issues. After an FDA inspection or an internal audit uncovers a non-compliance issue, it’s essential for companies to address the problem immediately to prevent further risks or violations.

Tip for Compliance: Establish a Corrective and Preventive Action (CAPA) plan that clearly outlines how issues should be addressed and the timeframe for implementing corrective actions. Ensure that all non-conformities are tracked and resolved efficiently.

5. Inconsistent Labeling and Packaging

Non-compliance with FDA labeling and packaging requirements is another common issue identified in Karapetyan’s inspections. Labels are required to provide accurate information about ingredients, dosage, usage instructions, and safety precautions. Inaccurate labeling can lead to severe consequences, including recalls or legal action.

Tip for Compliance: Regularly review labeling requirements and ensure all product labels meet FDA standards. Cross-check labeling for accuracy, including ingredient lists, safety warnings, and expiry dates.

Key Sectors Under Scrutiny in Karapetyan’s Inspections

While Karapetyan’s inspections span various industries, his focus areas are particularly relevant for the pharmaceutical and biotech sectors, where product safety is paramount. Here are some key sectors that have been under scrutiny in his inspections:

1. Pharmaceutical Manufacturing: This includes inspections of facilities that produce human and veterinary drugs. Ensuring GMP compliance, quality control, and proper documentation is critical in this sector.
2. Biotech and Medical Devices: Karapetyan also inspects companies that manufacture medical devices, ensuring they meet stringent FDA standards for safety, performance, and post-market surveillance.
3. Global Supply Chain and Raw Material Sourcing: With inspections in countries like India, China, and Canada, Karapetyan’s reports underscore the importance of ensuring that manufacturers source high-quality raw materials from compliant suppliers.

How Manufacturers Can Stay Ahead of FDA Inspections

To ensure ongoing compliance with FDA regulations and prepare for inspections, manufacturers can use the following strategies:

1. Adopt a Proactive Approach to Compliance: By regularly reviewing inspection reports and Form 483s, manufacturers can identify areas of improvement and proactively implement corrective actions before FDA inspections occur.
2. Invest in Training and Awareness: Regular training programs for staff on FDA regulations, GMP, and other compliance standards are vital for ensuring that everyone is aligned with regulatory expectations.
3. Monitor Supply Chain and Raw Material Quality: Ensure that suppliers and manufacturers adhere to strict quality standards. This can prevent violations related to product quality and safety.
4. Implement Continuous Improvement: Continuously review and improve quality control systems, documentation practices, and GMP adherence to avoid potential compliance issues.

Conclusion

Arsen Karapetyan’s inspections offer valuable insights into the recurring compliance challenges faced by pharmaceutical and biotech manufacturers. By focusing on key areas like GMP compliance, documentation accuracy, quality control, and labeling practices, companies can proactively address compliance issues before they result in Form 483s or violations.

Manufacturers looking to better understand inspection data and trends can benefit from insights provided by high-intelligence platforms like Atlas Compliance. By offering access to critical inspection reports and data, companies can predict future inspection trends, stay ahead of compliance risks, and ensure smoother, less stressful FDA inspections.