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

Analytics Overview

87
Form 483s Issued
11
483s converted to WL
97
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
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
20 Dec 2024
SCA Pharmaceuticals, LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
12
3
Justin A Boyd
8
1
Saleem A Akhtar
5
1
Joseph A Piechocki
5
0
Arsen Karapetyan
4
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: 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
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: The issue directly relates to the inadequacy in cleaning protocols and validation processes which are essential to Equipment Cleaning.
Excerpt: The protocols did not consider or justify, with data, the hardest to clean areas.
View Details
The cleaning of equipment is inadequate
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: Equipment cleaning is necessary to prevent product cross-contamination. Observation indicates failure in its execution as residues were found post-cleaning.
Excerpt: I observed a partially torn (b)(4)-based (b)(4) material stored directly within the vessel of (b)(4) 06, which was most recently used to process Batch No. (b)(4), step (b)(4).
View Details
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: The observation details visible residues and inadequate cleaning procedures, directly linked to Equipment Cleaning process deficiencies.
Excerpt: The non-dedicated GJC100-01 was not clean on January 16, 2025, with visible residues observed after initial cleaning inspection.
View Details
Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
SCA Pharmaceuticals, LLC		 20 Dec 2024 Normal Justification: The observation revolves around inadequately cleaned equipment parts, particularly HEPA filter diffusers, impacting cleanliness standards.
Excerpt: Your firm failed to adequately clean the LAFH to prevent potential cross-contamination.
View Details

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Go back

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
Share

Equipment Cleaning

Overview

87
Form 483s Issued
11
483s converted to WL
97
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
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
17 Feb 2025
Piramal Pharma Limited
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483
20 Dec 2024
SCA Pharmaceuticals, LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
12
3
Justin A Boyd
8
1
Saleem A Akhtar
5
1
Joseph A Piechocki
5
0
Arsen Karapetyan
4
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: 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
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: The issue directly relates to the inadequacy in cleaning protocols and validation processes which are essential to Equipment Cleaning.
Excerpt: The protocols did not consider or justify, with data, the hardest to clean areas.
View Details
The cleaning of equipment is inadequate
Piramal Pharma Limited		 17 Feb 2025 Normal Justification: Equipment cleaning is necessary to prevent product cross-contamination. Observation indicates failure in its execution as residues were found post-cleaning.
Excerpt: I observed a partially torn (b)(4)-based (b)(4) material stored directly within the vessel of (b)(4) 06, which was most recently used to process Batch No. (b)(4), step (b)(4).
View Details
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: The observation details visible residues and inadequate cleaning procedures, directly linked to Equipment Cleaning process deficiencies.
Excerpt: The non-dedicated GJC100-01 was not clean on January 16, 2025, with visible residues observed after initial cleaning inspection.
View Details
Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
SCA Pharmaceuticals, LLC		 20 Dec 2024 Normal Justification: The observation revolves around inadequately cleaned equipment parts, particularly HEPA filter diffusers, impacting cleanliness standards.
Excerpt: Your firm failed to adequately clean the LAFH to prevent potential cross-contamination.
View Details

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