Joseph Piachocki's FDA Inspection Reports: A Guide to Preparation

Preparing for FDA inspections is a crucial task for pharmaceutical manufacturers, and using inspector-specific data can greatly improve readiness. Joseph Piachocki, an active FDA inspector since 2021, has conducted 40 inspections, issuing 38 Form 483s and five warning letters.

His inspection reports highlight recurring compliance issues, particularly in areas like quality procedures and investigations. These insights provide a valuable roadmap for manufacturers to understand common pitfalls and strengthen their processes before inspections.

This blog explores Joseph Piachocki’s FDA inspection history, focusing on the key compliance issues he has identified. It also discusses how manufacturers can use his findings to enhance their inspection preparation, using AI platforms to develop effective compliance strategies and stay ahead of potential violations.

What do FDA Inspections Entail?

FDA inspections ensure that pharmaceutical manufacturers comply with regulations like Good Manufacturing Practices (GMP) and other standards under the Code of Federal Regulations (CFR). Inspectors focus on several critical areas during these inspections, including:

• Documentation and Recordkeeping: Ensuring accurate and complete records that demonstrate compliance with FDA standards.
• Quality Control and Assurance Procedures: Verifying that processes are in place to consistently meet product quality standards.
• Equipment Cleaning and Maintenance: Ensuring that manufacturing equipment is properly cleaned and maintained to prevent contamination.
• Component Testing and Specifications: Confirming that raw materials and components meet required specifications.
• Process Validation and Monitoring: Ensuring that manufacturing processes are validated and continuously monitored to maintain compliance.
• Corrective and Preventive Actions (CAPA): Evaluating how effectively the manufacturer identifies and addresses non-compliance issues.

Understanding these priorities helps manufacturers proactively address compliance gaps. Joseph Piachocki’s inspection reports provide actionable insights that can streamline preparation efforts, helping companies improve their regulatory preparedness and reduce the risk of violations.

Who Is Joseph Piachocki?

Joseph Piachocki has been an FDA inspector since 2021, conducting inspections in six countries: the United States, India, South Korea, Italy, China, and Jordan. While specific details about his designation, duty station, email, and phone are not publicly available, his extensive experience in pharmaceutical compliance makes his inspection findings highly valuable for manufacturers and regulatory professionals.

His insights are particularly relevant for Atlas Compliance’s audience, which includes pharmaceutical manufacturers, quality assurance teams, and regulatory affairs professionals. These individuals can use Piachocki’s reports to better align their operations with FDA standards, address common compliance issues, and improve their preparedness for inspections.

Joseph Piachocki’s Inspection History

Piachocki’s inspection record, though relatively new, is impactful, with the following key metrics as of May 2025:

• Total Inspections: 40
• Total 483s Issued: 38
• Total Warning Letters Issued: 5
• Average Inspection Duration: 9.62 days
• Inspection Duration Range: 3–44 days
• Inspections Last Year (2024): 12
• Inspections This Year (2025): 2

Piachocki’s high 483 issuance rate (38 out of 40 inspections) and longer average inspection duration (9.62 days) suggest thorough and rigorous evaluations. His recent activity, with 12 inspections in 2024 and 2 in 2025, indicates ongoing relevance in FDA oversight.

Key Compliance Issues in Piachocki’s 483s

Piachocki’s Form 483s highlight critical compliance issues, with the top five citations focusing on:

1. 21 CFR 211.22(d): Quality control procedures not documented or fully followed, compromising product safety.
2. 21 CFR 211.192: Inadequate investigations of discrepancies or failures, hindering corrective actions.
3. 21 CFR 211.67(b): Lack of established or followed written procedures for equipment cleaning and maintenance.
4. 21 CFR 211.84(d)(2): Failure to test each component for conformity with specifications, risking product quality.
5. 21 CFR 211.68(b): Inadequate computer control of master formula records, affecting manufacturing consistency.

These citations emphasize Piachocki’s focus on quality procedures, investigations, and documentation, areas that manufacturers must prioritize to ensure inspection readiness.

Recent Trends in Piachocki’s Inspections

Piachocki’s 12 inspections in 2024 and 2 in 2025 reflect a strong focus on pharmaceutical manufacturing compliance. His citations, particularly around quality procedures (21 CFR 211.22(d)) and investigations (21 CFR 211.192), align with FDA’s emphasis on robust documentation and process oversight.

His inspections across six countries, including emerging markets like India and China, highlight the importance of global compliance for multinational manufacturers. The lengthy inspection duration (up to 44 days) suggests in-depth scrutiny, making his data a critical resource for preparation.

Benefits of Using Piachocki’s Reports for Preparation

Joseph Piachocki’s inspection reports provide several key benefits for manufacturers preparing for FDA inspections:

1. Enhanced Quality Systems: By addressing citations related to 21 CFR 211.22(d) and 211.192, manufacturers can strengthen their quality control and investigation processes. This reduces the risk of violations and improves overall product quality.
2. Improved Documentation: Piachocki’s focus on written procedures and records highlights the importance of robust documentation practices. This ensures traceability and helps companies meet FDA standards for recordkeeping, which is crucial during inspections.
3. Proactive Compliance: His citations on areas like component testing and computer controls help manufacturers identify compliance gaps early. By addressing these issues proactively, manufacturers can avoid violations and be better prepared for FDA inspections.
4. Global Readiness: With inspections in countries like India and China, Piachocki’s reports provide valuable insights into FDA expectations for international facilities. This helps global manufacturers align their practices with FDA requirements, ensuring compliance across different markets.

These benefits support Atlas Compliance’s mission to provide AI-driven insights, enabling manufacturers to navigate complex regulatory requirements and enhance their overall compliance efforts.

How to Prepare Using Piachocki’s Data

To incorporate Joseph Piachocki’s inspection data for effective preparation, manufacturers can follow these steps:

• Review 483s for Patterns: Analyze Piachocki’s Form 483s to identify recurring issues, like inadequate quality procedures and investigations. By recognizing these patterns, manufacturers can prioritize corrective actions to address the most common areas of non-compliance.
• Strengthen Procedures and Testing: Conduct internal audits to ensure that documented procedures for equipment cleaning, component testing, and computer controls are in place. Align these practices with 21 CFR requirements to ensure compliance and reduce inspection risks.
• Utilize Atlas Compliance’s Tools: Incorporate Atlas Compliance’s AI-powered platform, which provides real-time access to Piachocki’s inspection data. Using natural language processing and predictive analytics, the platform helps manufacturers streamline their preparation efforts and take proactive steps to address potential compliance gaps.

Using Piachocki’s data strategically can give you a clear advantage when preparing for FDA inspections. By analyzing patterns and expectations, you can strengthen compliance efforts and reduce the risk of regulatory setbacks.

Conclusion

Joseph Piachocki’s 40 FDA inspections, 38 Form 483s, and five warning letters provide a critical guide for pharmaceutical manufacturers preparing for inspections. His focus on quality procedures, investigations, and documentation highlights key areas for improvement.

Atlas Compliance’s FDA inspection intelligence platform enables companies to access Piachocki’s reports, track compliance trends, and build robust preparation strategies.

Visit Atlas Compliance to discover how their tools can help your organization achieve FDA compliance and excel in inspection readiness.