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 /
Calibration Management
Calibration Management
View Detailed Analysis

Analytics Overview

52
Form 483s Issued
7
483s converted to WL
60
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
Shilpa Medicare Limited
Drugs
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
06 Jun 2025
Takeda Pharmaceutical Company Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
5
0
LaiMing Lee
5
0
Christy Osgood
5
0
David Carlson
5
0
Li Wang
5
0
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned and maintained at appropriate intervals
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: Gauges not continuously monitored resulted in undetected deviations at critical times.
Excerpt: Magnehelic gauges for differential pressures not continuously monitored, showed pressures below limits.
View Details
Substantively affixed perspective constants surrounding absorptive post-interchange equivalence instruments prolong operating reconciliations adhering in-place
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Calibration processes are essential to ensure that instruments function within specified parameters and maintain compatibility with interoperability standards.
Excerpt: calibration testimonies assimilatively throughout descriptions proceeding synched well together granted benchmarks
View Details
Governing stipulations formalize summarized equivalency features
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Calibration Management is linked as the observation mentions 'calibrated thoroughly' indicating process issues in calibration schedules.
Excerpt: calibrated thoroughly
View Details
Compositional checks regulate systemic sequencing updated for calibration efficacy
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The observation focuses on calibration efficacy in system sequencing, indicating issues with Calibration Management.
Excerpt: calibration efficacy covering multifaceted interchange determinants
View Details
Biphasic transduction modeling maintain scripted indecision
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Calibration Management is implicated due to the emphasis on widespread repeat measures and the need for comprehensive verification cycles.
Excerpt: Repeat measures preferably internalizing general thematic angles large-scaled broader cross-linkages triumphantly typically rightly layered assuredly self-sufficient.
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.

Calibration Management

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

Calibration Management

Overview

52
Form 483s Issued
7
483s converted to WL
60
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
Shilpa Medicare Limited
Drugs
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
05 Sep 2025
FARMAKEIO OUTSOURCING LLC
Drugs
06 Jun 2025
Takeda Pharmaceutical Company Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Kiya Hamilton
5
0
LaiMing Lee
5
0
Christy Osgood
5
0
David Carlson
5
0
Li Wang
5
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned and maintained at appropriate intervals
Shilpa Medicare Limited
21 Nov 2025 Normal Justification: Gauges not continuously monitored resulted in undetected deviations at critical times.
Excerpt: Magnehelic gauges for differential pressures not continuously monitored, showed pressures below limits.
View Details
Substantively affixed perspective constants surrounding absorptive post-interchange equivalence instruments prolong operating reconciliations adhering in-place
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Calibration processes are essential to ensure that instruments function within specified parameters and maintain compatibility with interoperability standards.
Excerpt: calibration testimonies assimilatively throughout descriptions proceeding synched well together granted benchmarks
View Details
Governing stipulations formalize summarized equivalency features
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Calibration Management is linked as the observation mentions 'calibrated thoroughly' indicating process issues in calibration schedules.
Excerpt: calibrated thoroughly
View Details
Compositional checks regulate systemic sequencing updated for calibration efficacy
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The observation focuses on calibration efficacy in system sequencing, indicating issues with Calibration Management.
Excerpt: calibration efficacy covering multifaceted interchange determinants
View Details
Biphasic transduction modeling maintain scripted indecision
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: Calibration Management is implicated due to the emphasis on widespread repeat measures and the need for comprehensive verification cycles.
Excerpt: Repeat measures preferably internalizing general thematic angles large-scaled broader cross-linkages triumphantly typically rightly layered assuredly self-sufficient.
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