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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

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Sub System
Penicillin Contamination

Penicillin Contamination

View Detailed Analysis

Analytics Overview

1
Form 483s Issued
0
483s converted to WL
2
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
25 Oct 2022
Eurovet Animal Health B.V.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
2
0
TITLE/ COMPANY Issue Date Status Details
Records are not kept for the cleaning of equipment
Eurovet Animal Health B.V.
25 Oct 2022 Normal Justification: Penicillin contamination control is crucial due to the omission of corrective action records for penicillin excursions.
Excerpt: No records of cleaning performed as a corrective action following Penicillin excursions in the sterile area.
View Details
The flow of components and drug products through the building is not designed to prevent contamination.
Eurovet Animal Health B.V.
25 Oct 2022 Normal Justification: Penicillin contamination is directly linked due to inadequate segregation and decontamination measures leading to cross-contamination.
Excerpt: Penicillin and non-penicillin raw materials are received at a common receiving location in the warehouse.
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.
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

Penicillin Contamination
/ Sub System

Cleaning Validation

FDA Trends & Compliance Insights for Pharma

Cleaning Validation is crucial for maintaining both product quality and regulatory compliance. In the pharmaceutical industry, any misstep in cleaning protocols can lead to costly FDA Form 483 observations or even Warning Letters. By staying aware of current trends and employing a structured, data-driven approach, manufacturers can ensure their processes remain audit-ready.



This page highlights the latest FDA trends and offers actionable insights for enhancing your facility’s cleaning validation outcomes.

Learn how automated validations, real-time residue tracking, and robust reporting can strengthen your FDA compliance approach.
8
 mins read

Penicillin Contamination

FDA Trends Overview

1
Form 483s Issued
0
483s converted to WL
2
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
25 Oct 2022
Eurovet Animal Health B.V.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Records are not kept for the cleaning of equipment
Eurovet Animal Health B.V.
25 Oct 2022 Normal Justification: Penicillin contamination control is crucial due to the omission of corrective action records for penicillin excursions.
Excerpt: No records of cleaning performed as a corrective action following Penicillin excursions in the sterile area.
View Details
The flow of components and drug products through the building is not designed to prevent contamination.
Eurovet Animal Health B.V.
25 Oct 2022 Normal Justification: Penicillin contamination is directly linked due to inadequate segregation and decontamination measures leading to cross-contamination.
Excerpt: Penicillin and non-penicillin raw materials are received at a common receiving location in the warehouse.
View Details

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Achieve Effortless Cleaning Validation Compliance
Pharmaceutical manufacturers trust Leucine’s Cleaning Validation software to ensure consistent, structured, and audit-ready validation processes. Say goodbye to manual errors and compliance headaches—adopt a smarter approach today