What Pratik Upadhyay Looks for During FDA Inspections—and How to Stay Compliant

FDA inspections are more than regulatory formalities; they can determine the future of your company’s ability to operate, export, and stay compliant. A single oversight during an inspection can lead to a Form 483, a warning letter, or even a shutdown. For pharmaceutical manufacturers, the stakes are even higher as patient safety is directly involved.

Among the FDA’s many field investigators, Pratik Upadhyay stands out for his detailed approach and consistent identification of systemic issues in CGMP (Current Good Manufacturing Practice) compliance. Since 2014, he has conducted over 93 inspections and issued 15 warning letters and typically inspects for 6–7 days per site, with some extending up to 17 days.

If you’re part of a Quality Assurance (QA) or Quality Control (QC) team in the pharmaceutical or life sciences industry, it’s essential to understand what inspectors like Upadhyay focus on and how to prepare for their audits. This article provides that clarity and gives you a proactive roadmap for audit-readiness.

Who is Pratik Upadhyay?

Pratik Upadhyay is a U.S. FDA investigator specializing in pharmaceutical manufacturing inspections. His inspection history shows a clear focus on cleaning validation, data integrity, documentation control, and failure investigations. Many of the warning letters he is involved with cite repeat or serious deficiencies that suggest systemic failure rather than isolated mistakes.

Understanding his inspection patterns can help pharmaceutical manufacturers strengthen compliance and reduce the risk of regulatory action.

For deeper insights, real-time inspection data, and a complete list of FDA observations, visit Atlas Compliance.

Key Areas of Focus During FDA Inspections by Pratik Upadhyay

1. Equipment Cleaning and Maintenance Failures

One of the most consistent observations in Upadhyay’s inspections is inadequate cleaning and maintenance of equipment. At multiple facilities, including Torrent Pharmaceuticals and Centaur Pharmaceuticals, he reported visible residues of active pharmaceutical ingredients (APIs) on equipment marked as ‘clean.’

Why this matters:
Improper cleaning between batches can lead to cross-contamination, compromising patient safety. This not only violates CGMP regulations under 21 CFR Part 211.67 but also suggests a lack of proper cleaning validation and procedural follow-through.

Real Impact:
FDA studies suggest that 30–40% of 483 observations related to equipment issues involve cleaning problems. Inadequate cleaning is one of the top five reasons for warning letters across pharmaceutical facilities globally.

Common Gaps Identified:

• Missing or outdated cleaning validation protocols

• No documentation of visual inspection

• Use of ineffective cleaning agents without proper justification

2. Poor Documentation and Data Integrity Issues

In several inspections, including at Mylan Laboratories and Hetero Labs, Upadhyay noted data falsification and incomplete batch records. Examples included altered test results, backdated entries, and missing records of critical processes.

Why this matters:
Data integrity is the foundation of CGMP compliance. Any compromise in how data is recorded, stored, or reported raises serious red flags with the FDA. Under 21 CFR Part 211.68 and 211.180, companies are required to maintain complete and accurate records.

Statistics:
According to the FDA, more than 70% of warning letters issued to drug manufacturers in 2023 cited data integrity lapses. In India and China, this percentage is even higher.

Issues commonly found:

• Test data altered after initial results

• Discrepancies between paper records and electronic logs

• Quality Unit is not reviewing the original data

3. Inadequate Investigation of OOS Results and Customer Complaints

Another area of concern in Upadhyay’s audits is how companies handle Out-of-Specification (OOS) results and customer complaints. At Otsuka Pharmaceuticals and Kolmar Korea, his findings revealed superficial or inconclusive investigations, often lacking a root cause or preventive actions.

Why this matters:
Failing to properly investigate complaints or OOS results can allow defective or unsafe products to remain in the market. FDA regulations (21 CFR 211.192) require a complete investigation and a scientifically sound conclusion for each discrepancy.

Common mistakes:

• Investigations closed without identifying a root cause

• No impact assessment on other batches or products

• Repeat issues with no CAPA (Corrective and Preventive Action)

Common Inspection Trends: A Snapshot of Upadhyay’s Inspection History

How Can QA Teams Prepare for Inspections? A Step-by-Step Readiness Plan

FDA inspections are becoming more targeted and data-driven. Preparing for inspectors like Upadhyay requires more than just clean rooms; it requires strong systems, updated SOPs, and a proactive culture of quality.

Step 1: Build Robust Cleaning Validation Programs

• Review all cleaning SOPs to ensure they reflect worst-case scenarios.

• Document all visual and analytical verification steps.

• Retest periodically and update procedures annually.

Pro Tip: Validate cleaning effectiveness for both highly soluble and poorly soluble APIs.

Step 2: Enforce Data Integrity Across All Units

• Provide Good Documentation Practice (GDP) training to all departments.

• Implement audit trails in all electronic systems.

• Create version control policies for paper-based records.

Pro Tip: Conduct internal audits specifically for data review and verification.

Step 3: Upgrade Your OOS and Complaint Investigation SOPs

• Investigations must include root cause analysis and risk assessment.

• Define clear steps in SOPs: detection, containment, investigation, resolution, and CAPA.

• Include product recall decision matrices in complaint SOPs.

Pro Tip: Involve cross-functional teams (QA, manufacturing, R&D) in all major investigations.

Step 4: Provide Targeted and Frequent CGMP Training

• Make training role-specific (e.g., cleaning staff vs. QA reviewers).

• Use real FDA 483 examples during training sessions.

• Conduct knowledge assessments quarterly.

Pro Tip: Keep training logs ready for review during inspections.

Step 5: Strengthen Quality Oversight and Documentation Culture

• QA must be involved in all batch release decisions.

• Use checklists for documentation review before archiving records.

• Review all SOPs for alignment with current regulatory expectations.

Pro Tip: Empower QA staff to raise concerns without fear of retaliation—a critical factor for data integrity.

FDA Investigator Pratik Upadhyay’s inspections provide a clear picture of what can go wrong in a pharmaceutical facility and what regulators expect. The repeated issues he identifies—such as poor cleaning, falsified records, and weak investigations—aren’t small mistakes; they reflect systemic weaknesses.

However, these weaknesses can be corrected with a strong internal quality system. With the right SOPs, training, oversight, and a culture of accountability, any company can meet and exceed FDA expectations.

The best time to prepare for an FDA inspection is before you get the notice. And the best way to prepare is to learn from others’ mistakes.