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Sub System /
Area Cleaning
Area Cleaning
View Detailed Analysis

Analytics Overview

108
Form 483s Issued
10
483s converted to WL
121
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
View Form 483
05 May 2026
Zydus Lifesciences Limited
Drugs
View Form 483
24 Apr 2026
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Drugs
View Form 483
27 Mar 2026
Q-Med AB
Drugs
View Form 483
26 Mar 2026
Elevate Surgical
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Scott T Ballard
8
0
Cody D Rickman
6
0
Christine M Smith
6
0
Emily A Walters
6
0
Hugh M Mcclure
6
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
There is a lack of written procedures assigning responsibility
RC Outsourcing, LLC		 03 Sep 2026 Normal Justification: Cleaning schedules and methods are critical to controlling contamination in cleanroom areas, affecting product sterility.
Excerpt: Your firm failed to clean the ISO 7 classified area...lacks scientifically established and data-supported cleaning intervals.
View Details
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: Area cleaning efficacy is directly impacted by surface conditions that do not support standard cleaning operations.
Excerpt: Floors within the Grade B cleanroom were visibly worn, peeling, and flaking in numerous locations.
View Details
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.		 24 Apr 2026 Normal Justification: The observation highlights significant issues in Area Cleaning, as improper techniques were used.
Excerpt: Discrepancies were noted during the cleaning performed on 20Apr2026 in workshop (b)(4).
View Details
Your firm's cleaning and disinfection program is inadequate to decontaminate
Q-Med AB		 27 Mar 2026 Normal Justification: The observation highlights specific failures in cleaning documentation (e.g., single log entries) directly related to area cleaning processes.
Excerpt: Your practice of using a single log entry...makes it impossible to verify that validated contact times were met.
View Details
Procedures for facility cleaning and sanitation were not established, maintained, defined, documented and implemented
Elevate Surgical		 26 Mar 2026 Normal Justification: The observation specifically highlights failures in cleaning procedures, which directly pertain to the 'Area Cleaning' process.
Excerpt: fails to specify requirements and documentation for facility cleaning and sanitation to prevent the spread of communicable diseases.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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Area Cleaning

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

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Area Cleaning

Overview

108
Form 483s Issued
10
483s converted to WL
121
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

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

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
03 Sep 2026
RC Outsourcing, LLC
Drugs
View Form 483
05 May 2026
Zydus Lifesciences Limited
Drugs
View Form 483
24 Apr 2026
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.
Drugs
View Form 483
27 Mar 2026
Q-Med AB
Drugs
View Form 483
26 Mar 2026
Elevate Surgical
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Scott T Ballard
8
0
Cody D Rickman
6
0
Christine M Smith
6
0
Emily A Walters
6
0
Hugh M Mcclure
6
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a lack of written procedures assigning responsibility
RC Outsourcing, LLC		 03 Sep 2026 Normal Justification: Cleaning schedules and methods are critical to controlling contamination in cleanroom areas, affecting product sterility.
Excerpt: Your firm failed to clean the ISO 7 classified area...lacks scientifically established and data-supported cleaning intervals.
View Details
Aseptic processing areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable.
Zydus Lifesciences Limited		 05 May 2026 Normal Justification: Area cleaning efficacy is directly impacted by surface conditions that do not support standard cleaning operations.
Excerpt: Floors within the Grade B cleanroom were visibly worn, peeling, and flaking in numerous locations.
View Details
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Jiangsu Hansoh Pharmaceutical Group Co. Ltd.		 24 Apr 2026 Normal Justification: The observation highlights significant issues in Area Cleaning, as improper techniques were used.
Excerpt: Discrepancies were noted during the cleaning performed on 20Apr2026 in workshop (b)(4).
View Details
Your firm's cleaning and disinfection program is inadequate to decontaminate
Q-Med AB		 27 Mar 2026 Normal Justification: The observation highlights specific failures in cleaning documentation (e.g., single log entries) directly related to area cleaning processes.
Excerpt: Your practice of using a single log entry...makes it impossible to verify that validated contact times were met.
View Details
Procedures for facility cleaning and sanitation were not established, maintained, defined, documented and implemented
Elevate Surgical		 26 Mar 2026 Normal Justification: The observation specifically highlights failures in cleaning procedures, which directly pertain to the 'Area Cleaning' process.
Excerpt: fails to specify requirements and documentation for facility cleaning and sanitation to prevent the spread of communicable diseases.
View Details

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