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Sub System /
Equipment Cleaning
Equipment Cleaning
View Detailed Analysis

Analytics Overview

117
Form 483s Issued
16
483s converted to WL
131
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
22 Jan 2026
Blendhouse Allerton, LLC
Drugs
22 Jan 2026
Excel Vision
Drugs
16 Jan 2026
Dabur India Limited
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
12
3
Justin A Boyd
9
0
Joseph A Piechocki
6
4
John Doe
5
0
Saleem A Akhtar
5
1
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: The issue fundamentally arises from inappropriate cleaning of equipment which is directly linked to Equipment Cleaning processes.
Excerpt: The (b)(4) non-dedicated (b)(4) used... have not been appropriately cleaned since their installation several years ago.
View Details
You did not ensure that all surfaces that contacted ingredients were cleaned and sanitized.
Blendhouse Allerton, LLC
22 Jan 2026 Normal Justification: Equipment Cleaning is involved as observation indicates a cleaning verification failure affecting operational cleanliness.
Excerpt: Management acknowledged that the record did not indicate that the procedure was followed.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment
Excel Vision
22 Jan 2026 Normal Justification: Equipment cleaning failures, particularly sterility, impact compliance in aseptic processes.
Excerpt: Equipment including the (b)(4) machine contact parts are not sterilized.
View Details
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment
Dabur India Limited
16 Jan 2026 Normal Justification: Equipment Cleaning process failed, leading to representation errors and cleaned inadequately for multi-product use.
Excerpt: The deliberate misrepresentation of equipment dedication, combined with the complete absence of cleaning validation...
View Details
Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive
Dabur India Limited
16 Jan 2026 Normal Justification: The stagnant fluid in hoses used for cleaning indicates a failure in equipment cleaning processes.
Excerpt: hoses connected to points of use in the Unit(b)(4) area and Unit(b)(4) manufacturing area were found to contain stagnant (b)(4).
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.

Equipment Cleaning

Overview

117
Form 483s Issued
16
483s converted to WL
131
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
22 Jan 2026
Blendhouse Allerton, LLC
Drugs
22 Jan 2026
Excel Vision
Drugs
16 Jan 2026
Dabur India Limited
Drugs
21 Nov 2025
Shilpa Medicare Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
12
3
Justin A Boyd
9
0
Joseph A Piechocki
6
4
John Doe
5
0
Saleem A Akhtar
5
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: The issue fundamentally arises from inappropriate cleaning of equipment which is directly linked to Equipment Cleaning processes.
Excerpt: The (b)(4) non-dedicated (b)(4) used... have not been appropriately cleaned since their installation several years ago.
View Details
You did not ensure that all surfaces that contacted ingredients were cleaned and sanitized.
Blendhouse Allerton, LLC
22 Jan 2026 Normal Justification: Equipment Cleaning is involved as observation indicates a cleaning verification failure affecting operational cleanliness.
Excerpt: Management acknowledged that the record did not indicate that the procedure was followed.
View Details
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment
Excel Vision
22 Jan 2026 Normal Justification: Equipment cleaning failures, particularly sterility, impact compliance in aseptic processes.
Excerpt: Equipment including the (b)(4) machine contact parts are not sterilized.
View Details
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment
Dabur India Limited
16 Jan 2026 Normal Justification: Equipment Cleaning process failed, leading to representation errors and cleaned inadequately for multi-product use.
Excerpt: The deliberate misrepresentation of equipment dedication, combined with the complete absence of cleaning validation...
View Details
Equipment surfaces that contact components and in-process materials are reactive, additive or absorptive
Dabur India Limited
16 Jan 2026 Normal Justification: The stagnant fluid in hoses used for cleaning indicates a failure in equipment cleaning processes.
Excerpt: hoses connected to points of use in the Unit(b)(4) area and Unit(b)(4) manufacturing area were found to contain stagnant (b)(4).
View Details

Frequently Asked Questions

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