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Sub System /
Batch Manufacturing
Batch Manufacturing
View Detailed Analysis

Analytics Overview

10
Form 483s Issued
1
483s converted to WL
10
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
03 Jul 2024
BSO LLC
Drugs
View Form 483
19 Jan 2024
Brassica Pharma Pvt Ltd
Drugs
View Form 483
11 Dec 2023
Torrent Pharmaceuticals Limited
Drugs
View Form 483
25 Oct 2023
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
10 Oct 2023
Fresenius Kabi Oncology Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
2
0
Anastasia M Shields
2
0
Camerson E Moore
1
0
Christina K Theodorou
1
0
Carolina D Vasquez
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
BSO LLC		 03 Jul 2024 Normal Justification: The issue directly relates to how batches are managed during manufacturing stages, specifically the lack of established timing protocols.
Excerpt: Your firm failed to establish a hold times between start of batch manufacturing and (b)(4) sterilization for Anastrozole.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products
Brassica Pharma Pvt Ltd		 19 Jan 2024 Normal Justification: The observation identifies gaps in documenting critical changes during batch manufacturing, implicating process management practices.
Excerpt: There was no documentation that had been made at the time of when the barriers were removed, why they were removed...
View Details
Components for drug product manufacturing are not weighed and measured
Torrent Pharmaceuticals Limited		 11 Dec 2023 Normal Justification: Batch manufacturing was directly implicated in the observation, as it involves the critical step of documenting component quantities, an essential aspect of the batch processing and record-keeping.
Excerpt: I observed on December 8, 2023 during the manufacturing run of (b)(4) for (b)(4) Capsules (b)mg, Batch # (b)(4), and reviewing of exhibit batch records for Batch # (b)(4) (b)(4) - (b)(4) mg) and (b)(4) (b)(4) (b)(4) mg) that you utilized a vessel of solution preparation (ID #TPL-ON-018) filled with (b)(4) solution to be used during the (b)(4) solution stage. However, the amount of the (b)(4) solution required is not listed and recorded in the batch manufacturing record (Form #FN.011.02-20.709E).
View Details
Your firm failed to establish adequate written procedures for production and process controls
Stokes Healthcare Inc. dba Epicur Pharma		 25 Oct 2023 Normal Justification: The problem extends to the batch manufacturing process, where products were released into the market without validated processes, which is a critical breach.
Excerpt: Approximately (b) (4) lots of both Tacrolimus AQ and Fluorouracil were manufactured and released for commercial distribution without validation.
View Details
Batch production and control records do not include complete information relating to the production and control of each batch.
Fresenius Kabi Oncology Limited		 10 Oct 2023 Normal Justification: The repeated issue of undocumented interventions points to broader manufacturing process inadequacies.
Excerpt: 12 interventions to clear a jammed vial at (b) (4) resulted in missing documentation.
View Details

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Back /
Batch Manufacturing
Sub-Systems

Batch Manufacturing

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

Batch Manufacturing

Overview

In the highly regulated world of pharmaceutical manufacturing, batch processing continues to be one of the most scrutinized areas by the U.S. FDA. Every year, the agency issues numerous Form 483s and Warning Letters that point to breakdowns in documentation, process control, and traceability during batch production.

What’s changing, however, is how these issues are being addressed. With the rise of Pharma 4.0 and modern Manufacturing Execution Systems (MES), pharma companies are increasingly moving from paper-based batch records to digital-first systems like Electronic Batch Records (EBRs). These technologies not only streamline manufacturing workflows but also help teams preempt common inspection risks.

10
Form 483s Issued
1
483s converted to WL
10
Total Observation
Form 483s Issued
+74 from last period

To understand how batch manufacturing is evolving and where the risks lie, we analyzed recent FDA enforcement data. Here’s what we found.

For context on what’s driving these observations and how you can reduce risk, explore related insights from:

FDA Trends

The FDA’s scrutiny of pharmaceutical batch manufacturing is intensifying — and not just in volume, but in specific areas of concern. Over the past 12–18 months, enforcement trends have centered on a familiar but unresolved set of compliance failures:

 Most Frequently Cited Issues:

  • Incomplete or missing batch production records
  • Lack of validation for critical manufacturing steps
  • Inadequate documentation of component measurements
  • Failure to follow written production procedures

These gaps not only disrupt regulatory inspections but also signal deeper inefficiencies in how batch data is captured, verified, and stored. As highlighted in our white paper on batch manufacturing risks, paper-based systems and siloed digital records often fail to provide the traceability and accountability the FDA now expects.

Why it matters

The number of Form 483s issued for batch-related failures has remained consistently high — and conversion rates to Warning Letters, though rare, typically follow repeat or unaddressed issues.

If you’re still relying on manual batch documentation or disconnected systems, you may be at greater risk of repeat findings and operational delays. Forward-thinking teams are shifting toward:

Learn how to modernize batch oversight with ourEBR implementation checklist or explorePharma 4.0 transformation strategies.

Form 483 Conversion Rate by Year
Form 483s Issued (Yearly)

Recent Form 483s & Warning Letters

Each Form 483 issued by the FDA reflects critical observations made during inspections — and in the context of batch manufacturing, they often highlight systemic gaps in process control, documentation, and compliance readiness. For more information on these FDA Form 483 observations focused on equipment qualification, one can review the detailed insights provided.

Below is a curated list of recent Form 483s issued to pharmaceutical facilities. These entries are sourced from Leucine’s FDA Tracker, a tool that gives regulatory and quality leaders real-time visibility into enforcement trends.

Key Takeaways:

  • BSO LLC and Brassica Pharma Pvt Ltd were recently issued 483s with no current conversion.
  • One firm (Torrent Pharmaceuticals) had observations around improper weighing and measurement — a classic batch documentation failure.
  • No current Warning Letters were issued among these facilities, but recurring documentation gaps raise red flags for future escalation.

Why it matters:
 Form 483s are not just enforcement tools — they’re a preview of deeper process failures. Addressing the root cause often requires more than SOP updates. Digitized execution and automated batch control are now critical to preventing repeat citations.

Learn how these trends align with the most cited FDA concerns:

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
03 Jul 2024
BSO LLC
Drugs
View Form 483
19 Jan 2024
Brassica Pharma Pvt Ltd
Drugs
View Form 483
11 Dec 2023
Torrent Pharmaceuticals Limited
Drugs
View Form 483
25 Oct 2023
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
10 Oct 2023
Fresenius Kabi Oncology Limited
Drugs
View Form 483

Top FDA Investigators

The outcome of an FDA inspection isn’t just influenced by what is found — but often who finds it. Each FDA investigator has a unique inspection pattern, depth of inquiry, and focus areas that impact the nature and volume of Form 483s issued.

These investigators have issued multiple observations related to:

  • Documentation lapses in batch production
  • Missing validation evidence
  • Poor adherence to master batch records (MBRs)

Why this matters:
Understanding an FDA investigator profile's prior focus areas can help teams anticipate likely findings and prepare accordingly. By using tools like Leucine’s FDA Investigator Profiles, QA/RA teams can analyze enforcement histories, benchmark patterns, and adapt their audit-readiness strategies proactively.

Related insights:
-Common 483 Trends in Batch Release & Records
-How to Use Investigator Intelligence for Audit Readiness

‍

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
2
0
Anastasia M Shields
2
0
Camerson E Moore
1
0
Christina K Theodorou
1
0
Carolina D Vasquez
1
0

Key Observations

Every observation issued in a Form 483 tells a story — usually about process gaps, missing documentation, or inconsistent control records. In batch manufacturing, these issues often arise in high-risk areas such as sterilization timing, solution preparation, and component verification.
TITLE/ COMPANY Issue Date Status Details
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
BSO LLC		 03 Jul 2024 Normal Justification: The issue directly relates to how batches are managed during manufacturing stages, specifically the lack of established timing protocols.
Excerpt: Your firm failed to establish a hold times between start of batch manufacturing and (b)(4) sterilization for Anastrozole.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products
Brassica Pharma Pvt Ltd		 19 Jan 2024 Normal Justification: The observation identifies gaps in documenting critical changes during batch manufacturing, implicating process management practices.
Excerpt: There was no documentation that had been made at the time of when the barriers were removed, why they were removed...
View Details
Components for drug product manufacturing are not weighed and measured
Torrent Pharmaceuticals Limited		 11 Dec 2023 Normal Justification: Batch manufacturing was directly implicated in the observation, as it involves the critical step of documenting component quantities, an essential aspect of the batch processing and record-keeping.
Excerpt: I observed on December 8, 2023 during the manufacturing run of (b)(4) for (b)(4) Capsules (b)mg, Batch # (b)(4), and reviewing of exhibit batch records for Batch # (b)(4) (b)(4) - (b)(4) mg) and (b)(4) (b)(4) (b)(4) mg) that you utilized a vessel of solution preparation (ID #TPL-ON-018) filled with (b)(4) solution to be used during the (b)(4) solution stage. However, the amount of the (b)(4) solution required is not listed and recorded in the batch manufacturing record (Form #FN.011.02-20.709E).
View Details
Your firm failed to establish adequate written procedures for production and process controls
Stokes Healthcare Inc. dba Epicur Pharma		 25 Oct 2023 Normal Justification: The problem extends to the batch manufacturing process, where products were released into the market without validated processes, which is a critical breach.
Excerpt: Approximately (b) (4) lots of both Tacrolimus AQ and Fluorouracil were manufactured and released for commercial distribution without validation.
View Details
Batch production and control records do not include complete information relating to the production and control of each batch.
Fresenius Kabi Oncology Limited		 10 Oct 2023 Normal Justification: The repeated issue of undocumented interventions points to broader manufacturing process inadequacies.
Excerpt: 12 interventions to clear a jammed vial at (b) (4) resulted in missing documentation.
View Details

Examples of Cited Issues:

  • BSO LLC: Failed to establish time limits between batch steps, risking compromised sterilization protocols.
  • Brassica Pharma Pvt Ltd: Lacked documentation for aseptic barrier removal — exposing gaps in environmental control.
  • Torrent Pharmaceuticals: Did not record solution quantities in the batch manufacturing record — a repeatable oversight.
  • Epicur Pharma: Released product without validated manufacturing processes.
  • Fresenius Kabi Oncology: Submitted incomplete production records, undermining traceability and accountability.

The Common Thread:
Across these observations, one thing is clear — manual and fragmented systems can’t keep up with FDA expectations. When documentation, validation, and operator logs are disconnected, the risk of inspection failure rises significantly.

How to Close the Gaps:
Digitizing your batch manufacturing records is no longer optional. Leading teams are adopting:

These tools ensure real-time recording, pre-defined process validation, and built-in compliance — dramatically reducing the likelihood of receiving similar citations.

Frequently Asked Questions

1. What are the most common FDA 483 observations in batch manufacturing process?

The FDA often cites issues like missing documentation, unvalidated batch steps, failure to follow written procedures, and incomplete control records. Many of these findings are linked to outdated, paper-based systems that lack traceability and compliance safeguards.
Explore: Top FDA 483 Observations in Batch Manufacturing

2. How can Electronic Batch Records (EBRs) help reduce inspection risks Batch Production Process?

EBRs eliminate manual entry errors, ensure real-time validation, and offer full traceability across production runs. They make it easier to comply with cGMP, quality control and data integrity requirements, especially during FDA audits.
Read: What Is an EBR?

3. What’s the difference between a Master Batch Record (MBR) and a Batch Manufacturing Record (BMR)?

An MBR is a predefined template for how a batch should be manufactured — it’s the gold standard. A BMR, on the other hand, is the actual execution record for a specific batch. Both need to be tightly controlled and traceable.
Related: Master Batch Record Guide

4. Can Leucine’s Batch Execution solution integrate with our existing systems?

Yes. Leucine’s platform is designed to integrate seamlessly with existing QMS, LIMS, and ERP systems. It provides a centralized layer for batch control without disrupting upstream or downstream systems.
‍

5. How fast can we go live with Leucine's batch manufacturing solution?

Many of our customers go live within 6–8 weeks, depending on their readiness level and SOP maturity. We provide onboarding support, compliance mapping, and validation documentation to accelerate time-to-value.

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