Join us at the 11th Global
Pharmaceutical Quality Summit 2026
Join us at the 11th Global
Pharmaceutical Quality Summit 2026
Experience Leucine AI .
Powered Pharma Operations

Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.

See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.

Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.

Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows

Connect with a Leucine Expert

Schedule a 30-Minute Product Demo with Expert Q&A

Sub System /
Sample Management
Sample Management
View Detailed Analysis

Analytics Overview

31
Form 483s Issued
8
483s converted to WL
43
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
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs
14 Oct 2025
UBI Pharma Inc.
Drugs
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
11
0
Kiya Hamilton
11
0
David Carlson
11
0
Christy Osgood
11
0
Li Wang
11
0
TITLE/ COMPANY Issue Date Status Details
Established sampling plans and test procedures are not followed and documented at the time of performance
Pharmathen International S.A.
21 Nov 2025 Normal Justification: Sample management involves tracking and documenting sampling activities as substantiated by observation in environmental sampling records.
Excerpt: Analysts were observed filling out the sampling information onto the paperwork during plate reading...
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited
21 Nov 2025 Normal Justification: Sample management issues are evident from missing reconciliation and unrecorded test details.
Excerpt: Quality unit has not reconciled all the received and tested samples with corresponding test results and reports.
View Details
Control procedures are not established which monitor the output and validate the performance
UBI Pharma Inc.
14 Oct 2025 Normal Justification: The observation describes insufficient detail in AQL sampling specifications leading to potential oversight in defects.
Excerpt: SOP No. P801 Version 5 fails to specify how to collect vials, nor you record the locations.
View Details
The adverse event of hypocalcemia occurred
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Sample Management is crucial in clinical studies to ensure accurate and timely assessments of participant health, yet this may have been inadequately managed.
Excerpt: The adverse event of hypocalcemia occurred in multiple subjects, yet was non-serious and not considered related to the study drug.
View Details
OSIS conducted an inspection for clinical sites at Parexel Early Phase Clinical Unit and Nuvisan GmbH, Germany for study RGB-14-001 under BLA 761439.
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The lack of documentation of subjects being supine before measurement relates to deficiencies in managing procedural documentation for sample processes.
Excerpt: Lack of documentation that subjects were supine for five minutes prior to supine blood pressure measurement.
View Details

Prepare Better for FDA Audits with FDA Tracker

Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
Stay Compliant: Manage risks proactively.

Sample Management

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Sample Management

Overview

31
Form 483s Issued
8
483s converted to WL
43
Total Observation
Form 483s Issued
+74 from last period

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs
14 Oct 2025
UBI Pharma Inc.
Drugs
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
11
0
Kiya Hamilton
11
0
David Carlson
11
0
Christy Osgood
11
0
Li Wang
11
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Established sampling plans and test procedures are not followed and documented at the time of performance
Pharmathen International S.A.
21 Nov 2025 Normal Justification: Sample management involves tracking and documenting sampling activities as substantiated by observation in environmental sampling records.
Excerpt: Analysts were observed filling out the sampling information onto the paperwork during plate reading...
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited
21 Nov 2025 Normal Justification: Sample management issues are evident from missing reconciliation and unrecorded test details.
Excerpt: Quality unit has not reconciled all the received and tested samples with corresponding test results and reports.
View Details
Control procedures are not established which monitor the output and validate the performance
UBI Pharma Inc.
14 Oct 2025 Normal Justification: The observation describes insufficient detail in AQL sampling specifications leading to potential oversight in defects.
Excerpt: SOP No. P801 Version 5 fails to specify how to collect vials, nor you record the locations.
View Details
The adverse event of hypocalcemia occurred
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Sample Management is crucial in clinical studies to ensure accurate and timely assessments of participant health, yet this may have been inadequately managed.
Excerpt: The adverse event of hypocalcemia occurred in multiple subjects, yet was non-serious and not considered related to the study drug.
View Details
OSIS conducted an inspection for clinical sites at Parexel Early Phase Clinical Unit and Nuvisan GmbH, Germany for study RGB-14-001 under BLA 761439.
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The lack of documentation of subjects being supine before measurement relates to deficiencies in managing procedural documentation for sample processes.
Excerpt: Lack of documentation that subjects were supine for five minutes prior to supine blood pressure measurement.
View Details

Frequently Asked Questions

Heading 1

Heading 2

Heading 3

Heading 4

Heading 5
Heading 6

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Block quote

Ordered list

  1. Item 1
  2. Item 2
  3. Item 3

Unordered list

  • Item A
  • Item B
  • Item C

Text link

Bold text

Emphasis

Superscript

Subscript

Experience Leucine AI Powered pharma manufacturing
300+ pharma facilities worldwide use Leucine to stay compliant. Talk to one of our expert consultants at Leucine to learn how.
Related Resources

View and learn more about FDA Inspections
with our comprehensive list of resources