Webinar : The Ultimate Cleaning Validation Blueprint · Aug 27 · 10 AM EST. Save Your Seat
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Sub System /
Area Cleaning
Area Cleaning
View Detailed Analysis

Analytics Overview

56
Form 483s Issued
10
483s converted to WL
59
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
27 Jun 2025
BSO, LLC
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
29 Apr 2025
East Orange VA Medical Center
Drugs
View Form 483
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Taichun Qin
5
1
Wayne Seifert
3
0
Jolanna A Norton
3
0
Pratik S Upadhyay
3
0
Yvins Dezan
3
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
BSO, LLC		 27 Jun 2025 Normal Justification: Area Cleaning process impacted as deviations involve floor cleaning, spray patterns, and PPE use.
Excerpt: Improper Floor Cleaning Technique: During floor cleaning with sporicidal agent, Technician did not follow the method.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment
Stokes Healthcare Inc. dba Epicur Pharma		 23 May 2025 Normal Justification: The cleaning issues directly affect the 'Area Cleaning' process type as they compromise the cleanliness of aseptic zones.
Excerpt: Specifically, A. The sporicidal agent used to clean the ISO 5 aseptic area did not meet the contact time specified.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Cleaning and disinfection practices were insufficient, posing a risk as highlighted by failure to disinfect items entering ISO 5.
Excerpt: Fail to consistently disinfect items, including the air particulate counter and bag of sterile wipes, before putting them into the ISO 5 hood.
View Details
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
East Orange VA Medical Center		 29 Apr 2025 Normal Justification: The mention of rust and discoloration indicates a lapse in cleaning protocols in critical production areas.
Excerpt: Rust was observed on the table legs of the work bench... Discoloration was observed on the HEPA pre-filter...
View Details
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Thrive Health and Wellness, LLC, dba Thrive Health Solutions		 03 Apr 2025 Normal Justification: Area Cleaning is critical as contamination risks are linked to difficulty in cleaning porous surfaces and clutter.
Excerpt: The benchtop table with shelves is cluttered with syringes, containers, utensils, binder clips, wipes, marker pens, and other supplies.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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Go back

Area Cleaning

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

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Area Cleaning

Overview

56
Form 483s Issued
10
483s converted to WL
59
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
27 Jun 2025
BSO, LLC
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
29 Apr 2025
East Orange VA Medical Center
Drugs
View Form 483
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Taichun Qin
5
1
Wayne Seifert
3
0
Jolanna A Norton
3
0
Pratik S Upadhyay
3
0
Yvins Dezan
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
BSO, LLC		 27 Jun 2025 Normal Justification: Area Cleaning process impacted as deviations involve floor cleaning, spray patterns, and PPE use.
Excerpt: Improper Floor Cleaning Technique: During floor cleaning with sporicidal agent, Technician did not follow the method.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment
Stokes Healthcare Inc. dba Epicur Pharma		 23 May 2025 Normal Justification: The cleaning issues directly affect the 'Area Cleaning' process type as they compromise the cleanliness of aseptic zones.
Excerpt: Specifically, A. The sporicidal agent used to clean the ISO 5 aseptic area did not meet the contact time specified.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Cleaning and disinfection practices were insufficient, posing a risk as highlighted by failure to disinfect items entering ISO 5.
Excerpt: Fail to consistently disinfect items, including the air particulate counter and bag of sterile wipes, before putting them into the ISO 5 hood.
View Details
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
East Orange VA Medical Center		 29 Apr 2025 Normal Justification: The mention of rust and discoloration indicates a lapse in cleaning protocols in critical production areas.
Excerpt: Rust was observed on the table legs of the work bench... Discoloration was observed on the HEPA pre-filter...
View Details
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Thrive Health and Wellness, LLC, dba Thrive Health Solutions		 03 Apr 2025 Normal Justification: Area Cleaning is critical as contamination risks are linked to difficulty in cleaning porous surfaces and clutter.
Excerpt: The benchtop table with shelves is cluttered with syringes, containers, utensils, binder clips, wipes, marker pens, and other supplies.
View Details

Frequently Asked Questions

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