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Sub System /
Equipment Cleaning
Equipment Cleaning
View Detailed Analysis

Analytics Overview

91
Form 483s Issued
16
483s converted to WL
102
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
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
27 Jun 2025
BSO, LLC
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
17 Feb 2025
Piramal Pharma Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
12
4
Justin A Boyd
8
3
Joseph A Piechocki
5
3
Saleem A Akhtar
5
1
Guerlain Ulysse
4
0
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Aurobindo Pharma Ltd.
05 Sep 2025 Normal Justification: The observation indicates a fundamental issue with cleaning processes for equipment, which is directly aligned with Equipment Cleaning.
Excerpt: The campaign length cleaning studies conducted... are not scientifically justified or defined.
View Details
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: Equipment Cleaning is compromised due to missing SOPs and validation, potentially affecting product cleanliness.
Excerpt: SOP PD291-01...instructs operators to solely use (b)(4) and a (b)(4) cloth...was not assessed.
View Details
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: The observation highlights visible stains and residue due to incomplete cleaning, detailing Equipment Cleaning as the core issue.
Excerpt: Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination.
View Details
Cleaning procedures for preventing cross-contamination are not scientifically validated
Not available
01 Aug 2025 Normal Justification: Issues in observation are related to ineffective equipment cleaning management, indicating gaps in Equipment Cleaning process.
Excerpt: The cleaning SOPs did not include detailed procedures for the disassembly and cleaning of the transfer pipes.
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: Equipment Cleaning process deviation is evident from the incorrect techniques and neglect of procedure specifics.
Excerpt: Technician did not follow the method outlined in Section 8.2.2 of WI 163.01, Cleanroom Cleaning Techniques.
View Details

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Equipment 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

Equipment Cleaning

Overview

91
Form 483s Issued
16
483s converted to WL
102
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
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
12 Aug 2025
Cohance Lifesciences Limited
Drugs
27 Jun 2025
BSO, LLC
Drugs
10 Apr 2025
Aurolige Pharma LLC
Drugs
17 Feb 2025
Piramal Pharma Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
12
4
Justin A Boyd
8
3
Joseph A Piechocki
5
3
Saleem A Akhtar
5
1
Guerlain Ulysse
4
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Aurobindo Pharma Ltd.
05 Sep 2025 Normal Justification: The observation indicates a fundamental issue with cleaning processes for equipment, which is directly aligned with Equipment Cleaning.
Excerpt: The campaign length cleaning studies conducted... are not scientifically justified or defined.
View Details
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: Equipment Cleaning is compromised due to missing SOPs and validation, potentially affecting product cleanliness.
Excerpt: SOP PD291-01...instructs operators to solely use (b)(4) and a (b)(4) cloth...was not assessed.
View Details
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination
Cohance Lifesciences Limited
12 Aug 2025 Normal Justification: The observation highlights visible stains and residue due to incomplete cleaning, detailing Equipment Cleaning as the core issue.
Excerpt: Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination.
View Details
Cleaning procedures for preventing cross-contamination are not scientifically validated
Not available
01 Aug 2025 Normal Justification: Issues in observation are related to ineffective equipment cleaning management, indicating gaps in Equipment Cleaning process.
Excerpt: The cleaning SOPs did not include detailed procedures for the disassembly and cleaning of the transfer pipes.
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: Equipment Cleaning process deviation is evident from the incorrect techniques and neglect of procedure specifics.
Excerpt: Technician did not follow the method outlined in Section 8.2.2 of WI 163.01, Cleanroom Cleaning Techniques.
View Details

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