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 /
Laboratory Controls
Laboratory Controls
View Detailed Analysis

Analytics Overview

136
Form 483s Issued
23
483s converted to WL
170
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 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
20 Mar 2026
Bora Pharmaceuticals Injectables Inc
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
24
6
Justin A Boyd
14
4
Anastasia M Shields
11
4
Patty P Kaewussdangkul
8
3
Pratik S Upadhyay
6
1
TITLE/ COMPANY Issue Date Status Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: The inadequate establishment of testing specifications directly impacts laboratory controls, as seen in failed subvisible particle limits.
Excerpt: Your firm continues to fail to provide a scientific rationale to support the established method and limits.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications...
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: The observation specifically notes a lack of scientifically sound specifications and test procedures, directly implicating Laboratory Controls.
Excerpt: Your firm was unable to provide scientific data or justification demonstrating that a release specification is appropriate...
View Details
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Laboratory controls require validated and qualified methods to ensure test reliability and compliance.
Excerpt: Your firm uses the (b)(4) system for confirmatory identification of microorganisms, using methods that are not validated.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Novel Laboratories, Inc. d.b.a Lupin
17 Apr 2026 Normal Justification: The issue relates to inadequate laboratory controls over data management resulting from non-validated spreadsheets.
Excerpt: These spreadsheets were observed to lack ... cell protection, audit trail functionality, and electronic signature controls.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate standards
Bora Pharmaceuticals Injectables Inc
20 Mar 2026 Normal Justification: The issue directly pertains to laboratory testing methods which are integral to Laboratory Controls.
Excerpt: Specifically, A. The (b) (4) HPLC method lacks full optimization, accuracy, and robustness for its intended use.
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.

Laboratory Controls

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

Laboratory Controls

Overview

136
Form 483s Issued
23
483s converted to WL
170
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
03 Sep 2026
RC Outsourcing, LLC
Drugs
18 Aug 2026
Imprimis NJOF, LLC
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
20 Mar 2026
Bora Pharmaceuticals Injectables Inc
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
24
6
Justin A Boyd
14
4
Anastasia M Shields
11
4
Patty P Kaewussdangkul
8
3
Pratik S Upadhyay
6
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: The inadequate establishment of testing specifications directly impacts laboratory controls, as seen in failed subvisible particle limits.
Excerpt: Your firm continues to fail to provide a scientific rationale to support the established method and limits.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications...
Imprimis NJOF, LLC
18 Aug 2026 Normal Justification: The observation specifically notes a lack of scientifically sound specifications and test procedures, directly implicating Laboratory Controls.
Excerpt: Your firm was unable to provide scientific data or justification demonstrating that a release specification is appropriate...
View Details
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Laboratory controls require validated and qualified methods to ensure test reliability and compliance.
Excerpt: Your firm uses the (b)(4) system for confirmatory identification of microorganisms, using methods that are not validated.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Novel Laboratories, Inc. d.b.a Lupin
17 Apr 2026 Normal Justification: The issue relates to inadequate laboratory controls over data management resulting from non-validated spreadsheets.
Excerpt: These spreadsheets were observed to lack ... cell protection, audit trail functionality, and electronic signature controls.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate standards
Bora Pharmaceuticals Injectables Inc
20 Mar 2026 Normal Justification: The issue directly pertains to laboratory testing methods which are integral to Laboratory Controls.
Excerpt: Specifically, A. The (b) (4) HPLC method lacks full optimization, accuracy, and robustness for its intended use.
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