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

58
Form 483s Issued
10
483s converted to WL
61
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
01 Aug 2025
Not available
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
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

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
Personnel practices within the facility do not adequately prevent microbial contamination of drug product.
Not available		 01 Aug 2025 Normal Justification: Area Cleaning is compromised, shown by contaminants like skin flakes and hair in critical zones.
Excerpt: Hair follicles and skin flakes were present in the Grade A aseptic processing area...
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Critical records for verifying sterility were not maintained, essential for process validation.
Excerpt: Your firm has no cleaning records from August 2024 to July 2025.
View 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

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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.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Area Cleaning

Overview

58
Form 483s Issued
10
483s converted to WL
61
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
01 Aug 2025
Not available
Drugs
View Form 483
18 Jul 2025
GenoGenix, LLC
Drugs
View Form 483
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

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
Personnel practices within the facility do not adequately prevent microbial contamination of drug product.
Not available		 01 Aug 2025 Normal Justification: Area Cleaning is compromised, shown by contaminants like skin flakes and hair in critical zones.
Excerpt: Hair follicles and skin flakes were present in the Grade A aseptic processing area...
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Critical records for verifying sterility were not maintained, essential for process validation.
Excerpt: Your firm has no cleaning records from August 2024 to July 2025.
View 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

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