Dipesh Shah, USFDA Inspector: Key Reports and Regulatory Actions

Dipesh Shah has had a prominent role in ensuring regulatory compliance within the pharmaceutical industry. With 191 inspections and 163 Form 483s issued, his inspection history highlights the critical importance of maintaining strict adherence to FDA standards.
This article explores the key aspects of Shah's inspections, including his role in issuing warning letters, the duration of his inspections, and the global scope of his work.
We'll also look at what businesses can learn from his inspections to strengthen their own compliance efforts.

Dipesh Shah's FDA Inspector Profile

As a Consumer Safety Officer stationed in Silver Spring, Maryland, Dipesh Shah, USFDA https://www.atlas-compliance.ai/inspectorDetail/Dipesh_K_Shah , has been actively involved in inspecting pharmaceutical manufacturing facilities worldwide. His inspections have covered a wide range of companies in various countries, ensuring that they meet the stringent standards required for product safety and public health.
Total Inspections: 191
Form 483s Issued: 163
Warning Letters Issued: 17
The high number of Form 483s issued by Shah underscores the thoroughness of his inspections. These forms highlight areas where companies have fallen short of FDA requirements. They serve as a warnings to address compliance issues before they lead to more severe consequences.

Key Areas FDA Inspectors Focus on During Inspections

FDA inspectors like Dipesh Shah typically focus on several core areas to ensure compliance:

Good Manufacturing Practices (GMP): Ensuring that facilities follow standardized processes to maintain product quality.

Quality Control and Assurance: Verifying that products meet safety standards and are consistently manufactured.

Labeling Compliance: Ensuring that product labels adhere to FDA guidelines and accurately represent the contents.

Facility Conditions: Inspecting the cleanliness and maintenance of the facility to avoid contamination risks.

Employee Training and SOPs: Reviewing staff qualifications and adherence to established procedures.

Notable Recent Inspections

Some of the notable companies inspected by Dipesh Shah include well-known names like Baxter Healthcare https://www.baxter.com/ , Alkem Laboratories, and Metrochem API Pvt Limited. Below are some of the key inspections:
Baxter Healthcare (Guangzhou) Co., Ltd., China - December 13, 2024
Marksans Pharma Limited, India - April 17, 2024
Inner Mongolia Changsheng Pharmaceutical Co., Ltd., China - November 13, 2024
Fusion Scientific Laboratories Pvt. Ltd., India - December 8, 2023
Alkem Laboratories Limited, India - December 1, 2023
These inspections, often resulting in 483 forms or warnings, provide critical insights into ongoing regulatory challenges faced by the pharmaceutical sector.

Year-Wise Inspection Overview

The following year-wise breakdown highlights the consistency and breadth of Shah's inspections:
2008: 18 inspections
2010: 8 inspections
2012: 22 inspections
2015: 13 inspections
2022: 11 inspections
2024: 7 inspections (so far)
This extensive record showcases Shah's commitment to maintaining global regulatory standards, reinforcing the FDA's mission to protect public health.

The Role of Form 483s in Regulatory Compliance

Form 483 is issued when an FDA investigator identifies conditions that do not meet regulatory standards. These forms are crucial for initiating corrective actions within companies.

Dipesh Shah has issued 163 Form 483s throughout his career, emphasizing the importance of addressing potential issues before they become larger problems.

Total 483s Issued: 163 (85.3% of inspections)
Form 483s signal that companies are not fully compliant and need to take corrective measures to avoid future regulatory actions. By addressing these issues early, companies can prevent issues from escalating into warning letters or more severe penalties, protecting their operations and reputation.
Warning Letters: Consequences of Persistent Non-Compliance

While Form 483s are common, warning letters are a more severe form of action, indicating that a company has failed to address serious or recurring regulatory violations.
Dipesh Shah has issued 17 warning letters, which suggests that a small percentage of companies failed to take the necessary corrective actions after receiving Form 483s.

Warning Letters Issued: 17 (8.9% of inspections)
For companies, receiving a warning letter is a serious matter. It is a signal that non-compliance has reached a critical point, and if not addressed immediately, further regulatory penalties may follow.
Shah's record shows that warning letters are issued when companies fail to meet the FDA's stringent standards, emphasizing the importance of maintaining ongoing compliance.

Inspection Duration: Insights Into the Depth of Review
The length of Shah's inspections provides valuable insight into the level of scrutiny applied during each visit. With inspection durations ranging from as little as 1 day to 23 days, the variation highlights that some facilities require more thorough evaluations than others.
Shortest Inspection: 1 day
Longest Inspection: 23 days
Average Length of Inspection: 4.3 days

Shorter inspections could indicate that the facility is largely compliant, while longer inspections often point to more complex issues that require deeper investigation.
For companies, this emphasizes the need for readiness for inspections of varying durations and the importance of being prepared for comprehensive reviews of their operations.

Global Reach: Shah's Inspections Across Borders
Dipesh Shah's inspections span numerous countries, showcasing the FDA's global oversight in ensuring product safety. Shah has worked in countries such as India, China, and the United States, underscoring the FDA's worldwide regulatory influence.

Active Locations Include:

United States
India
China
Costa Rica
South Korea
Canada
Malaysia
For companies with international operations, this global scope reinforces the need to maintain consistent compliance across all facilities.
Multinational companies must ensure that they meet FDA standards https://www.fda.gov/regulatory-information/fda-standards-program regardless of their location to prevent regulatory issues from arising during inspections.

Co-Inspectors: A Collaborative Approach to Thorough Inspections

Shah frequently works with co-inspectors to ensure a comprehensive review of pharmaceutical facilities. This collaborative approach brings additional expertise to the inspection process, ensuring that all aspects of the facility are thoroughly examined.

Notable Co-Inspectors Include:
Arsen Karapetyan: 3 inspections
Rajiv R Srivastava: 4 inspections (2022)
Saleem A Akhtar: 2 inspections (2023)
Co-inspectors bring different areas of expertise, which enhances the thoroughness of each inspection.

For companies, this means they must be prepared for inspections that involve multiple experts assessing various aspects of their operations, from quality control to manufacturing practices.

Key Insights for Companies from Dipesh Shah's FDA Inspections

The inspection data from Dipesh Shah offers several actionable insights for companies looking to improve their compliance efforts:

Regular Internal Audits: Proactively addressing potential issues through internal audits helps prevent non-compliance from being flagged during FDA inspections.

Timely Corrective Actions: Companies should act quickly to resolve any issues identified in Form 483s to prevent further regulatory actions like warning letters.

Consistent Global Compliance: Multinational companies must ensure that their compliance practices are consistent across all locations to avoid discrepancies that could trigger inspections.

Thorough Documentation: Keeping detailed records of processes and corrective actions shows the FDA that a company is committed to maintaining high standards.

Employee Training: Ensuring all employees understand FDA regulations and compliance standards helps streamline the inspection process and improves overall performance.

Conclusion

Dipesh Shah's USFDA inspection history highlights the importance of proactive compliance. The high number of Form 483s issued shows that addressing issues early can prevent escalation into warning letters.
Shah's record emphasizes the need for regular audits, thorough training, and consistent global compliance.
For businesses aiming to improve their inspection preparedness, organizations like Atlas Compliance https://www.atlas-compliance.ai/ provide the tools to turn FDA inspection data into actionable insights. Schedule a demo today to see how Atlas Compliance can help your business stay inspection-ready.

Islamabad, Pakistan

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This release was published on openPR.