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OBSERVATION 4 The firm does not maintain complete and accurate batch production and control records for its drug products. Not available
01 Aug 2025
Normal
Justification: Batch Records are essential for traceability and compliance; lapses affect process validation adherence and integrity. Excerpt: Batch records for API Batch #1123 were missing documentation for critical process step verification. View Details
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months GenoGenix, LLC
18 Jul 2025
Normal
Justification: The reporting failure suggests a lapse in maintaining or accessing complete and accurate batch records for reporting. Excerpt: Your outsourcing facility did not submit a report to FDA identifying all the drugs compounded during the previous six-month period. View Details
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. Right Value Drug Stores LLC
18 Jul 2025
Normal
Justification: Proper documentation in batch records is crucial for ensuring each step in the manufacturing process, like needle change, is verified. Excerpt: The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step. View Details
Drug product production and control records, are not reviewed and approved by the quality control unit Dr. Reddy's Laboratories Limited , FTO-11
18 Jul 2025
Normal
Justification: The observation shows a deficiency in the review process, particularly missing critical verification steps and supporting data. Excerpt: The Batch record review by quality unit was deficient as it was not able to detect the supporting raw data were missing. View Details
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product GenoGenix, LLC
18 Jul 2025
Normal
Justification: Batch Records must reflect accurate inspection details, which they failed to in this observation. Excerpt: Step 5.2.3 indicated that all vials passed 100% visual inspection; however, your actual practice does not include particulate inspection for amber vials. View Details
Prepare Better for FDA Audits with FDA Tracker
Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.
Written By
Vivek Gera
Reading Time
8
Minutes
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Learn how automated validations, real-time residue tracking, and robust reporting can strengthen your FDA compliance approach.
The FDA’s enforcement data reveals a growing compliance gap in how pharmaceutical manufacturers handle batch records — especially as facilities transition from paper-based to electronic systems. Over the past three years, inspectional observations related to electronic batch records (EBRs) and master batch records have surged, with recurring citations tied to data integrity, incomplete documentation, and procedural gaps.
108
Form 483s Issued
26
483s converted to WL
137
Total Observation
Form 483s Issued
+74 from last period
In 2024 alone, over 70 Form 483s specifically cited failures in batch documentation — from missing signatures to incomplete data capture during the manufacturing process. Many of these escalated into Warning Letters, particularly when firms lacked effective corrective actions or continued using fragmented paper-based systems that could not ensure traceability.
This shift underscores the FDA’s increasing scrutiny of:
Inadequate batch record reviews
Non-validated digital systems
Manual overrides without audit trails
The agency's pivot is clear: digital systems are no longer optional — they are expected.
"The firm’s batch production and control records did not include complete data derived from all testing conducted." — FDA Form 483 Observation, 2024
Manufacturers relying on static, non-integrated recordkeeping are now disproportionately flagged — often by repeat FDA investigators with a focus on batch record compliance. The message is unmistakable: companies that fail to digitize and integrate risk not only citations but also production delays, recalls, and reputational damage.
Stay Audit-Ready Always
Meet 21 CFR Part 11 with digital records, secure signatures, and tamper-proof audit trails.
The FDA data shows a sharp increase in inspectional observations tied to batch record compliance — with a significant portion escalating into Warning Letters. This trend aligns with the FDA’s heightened focus on data integrity and digital traceability across pharmaceutical manufacturing
Across this period, violations associated with master batch records, recordkeeping gaps, and electronic batch record inconsistencies were the most cited.
These enforcement spikes reflect a larger shift — not just in FDA priorities, but in expectations around system maturity. Manufacturers who cannot demonstrate real-time, end-to-end batch data integrity are increasingly viewed as high-risk operations.
Manufacturers still dependent on paper-based documentation or siloed legacy systems face a disproportionately high rate of Form 483s and compliance citations.
Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)
Standardize Every Batch Run
Reduce the risk of escalating 483s with real-time residue tracking and robust documentation.
The following 483s and Warning Letters reveal a consistent pattern, batch record-related violations are no longer isolated, they are systemic. Across both U.S. and global facilities, FDA investigators are issuing citations for incomplete digital records, missing data from master batch records, and lack of proper review procedures.
FDA’s inspectional focus on batch record compliance is not random — it is heavily driven by a core group of seasoned investigators. These individuals have issued a disproportionate number of Form 483s and Warning Letters related to deficiencies in electronic batch records, master batch records, and data traceability.
Who’s Driving Enforcement?
Analysis from FDA Tracker reveals that the top 5 investigators issued over 30 batch record-related citations in the past 12 months alone. Their findings repeatedly target:
Incomplete or missing entries in batch production records
Delayed or absent batch reviews before product release
Unvalidated or non-compliant electronic systems
Lack of secure, audit-traceable digital records
"Your firm failed to establish adequate procedures for batch production and control. The master batch record lacked signatures, and batch verification was not documented." — Observation issued by Investigator
These investigators often revisit the same facility class (e.g., sterile, oncology, API) and expect escalating improvement. If you’ve been previously cited for batch record issues, expect a follow-up — with tighter scrutiny.
Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
19
10
Pratik S Upadhyay
11
4
Anastasia M Shields
8
5
Nibin Varghese
5
3
Joseph A Piechocki
5
1
Know Your FDA Inspector
Track citations, trends, and risks using real-time data from 483s and warning letters.
FDA investigators have cited a wide range of issues related to batch documentation — many of which trace back to flawed or incomplete master batch records, paper-based log sheets, or unvalidated electronic systems. Here are the most frequent compliance breakdowns uncovered in recent audits:
TITLE/ COMPANY
Issue Date
Status
Details
OBSERVATION 4 The firm does not maintain complete and accurate batch production and control records for its drug products. Not available
01 Aug 2025
Normal
Justification: Batch Records are essential for traceability and compliance; lapses affect process validation adherence and integrity. Excerpt: Batch records for API Batch #1123 were missing documentation for critical process step verification. View Details
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months GenoGenix, LLC
18 Jul 2025
Normal
Justification: The reporting failure suggests a lapse in maintaining or accessing complete and accurate batch records for reporting. Excerpt: Your outsourcing facility did not submit a report to FDA identifying all the drugs compounded during the previous six-month period. View Details
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. Right Value Drug Stores LLC
18 Jul 2025
Normal
Justification: Proper documentation in batch records is crucial for ensuring each step in the manufacturing process, like needle change, is verified. Excerpt: The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step. View Details
Drug product production and control records, are not reviewed and approved by the quality control unit Dr. Reddy's Laboratories Limited , FTO-11
18 Jul 2025
Normal
Justification: The observation shows a deficiency in the review process, particularly missing critical verification steps and supporting data. Excerpt: The Batch record review by quality unit was deficient as it was not able to detect the supporting raw data were missing. View Details
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product GenoGenix, LLC
18 Jul 2025
Normal
Justification: Batch Records must reflect accurate inspection details, which they failed to in this observation. Excerpt: Step 5.2.3 indicated that all vials passed 100% visual inspection; however, your actual practice does not include particulate inspection for amber vials. View Details
Capture Records Digitally
Automate exceptions and reviews to accelerate compliance and batch release.
1. Why is the FDA focusing more on batch records during inspections?
Batch records are the foundation of product quality and GMP compliance. The FDA has observed rising inconsistencies in how these records are managed — especially in firms still using manual, paper-based systems. Missing signatures, undocumented steps in the manufacturing process, and lack of corrective action tracking are now leading causes of Form 483s.
2. What’s the difference between a Master Batch Record and a Batch Production Record?
Master Batch Record (MBR): Pre-approved template that outlines the complete manufacturing process.
Batch Production Record (BPR): The execution record for a specific batch, based on the MBR.
Both must be accurate, reviewed, and securely stored — ideally as digital records within a validated electronic system.
3. Are electronic batch records (EBRs) FDA compliant?
Yes — if implemented correctly. A compliant electronic batch record system must:
4. How can digital records prevent Form 483s and Warning Letters?
Digital systems eliminate gaps caused by:
Manual data entry errors
Delayed batch reviews
Lost or illegible records
They also allow faster detection and resolution of deviations, which reduces the risk of enforcement.
5. Do I need an MES to implement electronic batch records?
Not necessarily. Leucine’s MDF Batch Record can be deployed as a standalone solution or integrated with your existing MES to enhance data capture, equipment connectivity, and real-time oversight.
6. How do I prepare for an FDA inspection if I’ve recently digitized my batch records?
Start with:
A full validation report of your EBR system
Staff training records
Demonstration of corrective action workflows
Use FDA Tracker to monitor enforcement trends and investigator profiles before the audit.
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