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Sub System /
Area Cleaning

Analytics Overview

66
Form 483s Issued
10
483s converted to WL
69
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
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
16 Sep 2025
Fareva Amboise
Drugs
03 Sep 2025
Biocon Biologics Limited
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Yvins Dezan
4
0
Taichun Qin
4
1
Jolanna A Norton
3
0
José E Melendez
3
0
Pratik S Upadhyay
3
0
TITLE/ COMPANY Issue Date Status Details
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Empower Clinic Services, L.L.C. dba Empower Pharma
14 Nov 2025 Normal Justification: The observation is directly linked to 'Area Cleaning', as failure in executing cleaning protocols led to potential contamination.
Excerpt: Per the firm's procedure ... cleaning shall be completed prior to the formulation of different active sterile injectable lots.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment
Fresenius Kabi Compounding, LLC
06 Nov 2025 Normal Justification: The observation highlights deficiencies in cleaning tasks related to maintaining aseptic conditions.
Excerpt: A brown, rust-like residue was observed on the (b) (4) of multiple tables and laminar flow hoods...
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions
Fareva Amboise
16 Sep 2025 Normal Justification: The observation highlights procedural errors during area cleaning affecting aseptic conditions.
Excerpt: Operators did not use a unidirectional wiping technique or clean and disinfect the area in the product flow direction.
View Details
Written sanitation and facility maintenance procedures are not established or followed
Biocon Biologics Limited
03 Sep 2025 Normal Justification: Observation mentions 'soiled mop labeled as Grade D Area Cleaning' and 'standing liquid puddles,' highlighting an Area Cleaning issue.
Excerpt: A soiled mop labeled as "Grade D Area Cleaning" within the Grade C room and liquid standing puddles.
View 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

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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.

Area Cleaning

Overview

66
Form 483s Issued
10
483s converted to WL
69
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
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
16 Sep 2025
Fareva Amboise
Drugs
03 Sep 2025
Biocon Biologics Limited
Drugs
18 Jul 2025
GenoGenix, LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Yvins Dezan
4
0
Taichun Qin
4
1
Jolanna A Norton
3
0
José E Melendez
3
0
Pratik S Upadhyay
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Empower Clinic Services, L.L.C. dba Empower Pharma
14 Nov 2025 Normal Justification: The observation is directly linked to 'Area Cleaning', as failure in executing cleaning protocols led to potential contamination.
Excerpt: Per the firm's procedure ... cleaning shall be completed prior to the formulation of different active sterile injectable lots.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment
Fresenius Kabi Compounding, LLC
06 Nov 2025 Normal Justification: The observation highlights deficiencies in cleaning tasks related to maintaining aseptic conditions.
Excerpt: A brown, rust-like residue was observed on the (b) (4) of multiple tables and laminar flow hoods...
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions
Fareva Amboise
16 Sep 2025 Normal Justification: The observation highlights procedural errors during area cleaning affecting aseptic conditions.
Excerpt: Operators did not use a unidirectional wiping technique or clean and disinfect the area in the product flow direction.
View Details
Written sanitation and facility maintenance procedures are not established or followed
Biocon Biologics Limited
03 Sep 2025 Normal Justification: Observation mentions 'soiled mop labeled as Grade D Area Cleaning' and 'standing liquid puddles,' highlighting an Area Cleaning issue.
Excerpt: A soiled mop labeled as "Grade D Area Cleaning" within the Grade C room and liquid standing puddles.
View 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

Frequently Asked Questions

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