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Sub System /
Equipment Cleaning
Equipment Cleaning
View Detailed Analysis

Analytics Overview

138
Form 483s Issued
16
483s converted to WL
152
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
01 May 2026
Alkem Laboratories Limited
Drugs
23 Mar 2026
Cerovene Inc.
Drugs
20 Mar 2026
Bora Pharmaceuticals Injectables Inc
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
Saleem A Akhtar
6
1
John Doe
5
0
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: The equipment cleaning process is fundamentally linked as residues indicate the cleaning process was inefficacious.
Excerpt: Residues were observed on the top of the HEPA filter housing...indicating a failure in the cleaning protocol.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Emcure Pharmaceuticals Limited
15 May 2026 Normal Justification: Residue accumulation on equipment directly implicates Equipment Cleaning processes.
Excerpt: Multiple locations within ISO 5 had residues on surfaces, indicating cleaning failures.
View Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions
Alkem Laboratories Limited
01 May 2026 Normal Justification: The presence of rust and water droplets suggests leaks and improper cleaning maintenance, impacting Equipment Cleaning processes.
Excerpt: Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination.
View Details
(Repeat) Equipment and utensils are not cleaned, maintained at appropriate intervals
Cerovene Inc.
23 Mar 2026 Normal Justification: The observation detailed cleaning issues directly related to improper equipment cleaning processes.
Excerpt: Presence of white caked residue in Capsule Machine ID and white powder inside validation locations.
View Details
Written procedures are not followed for the cleaning and maintenance of equipment
Bora Pharmaceuticals Injectables Inc
20 Mar 2026 Normal Justification: Observation directly relates to the ineffectiveness of equipment cleaning procedures, as disinfectant residue compromises equipment sterility.
Excerpt: The procedure indicates for equipment...to be wiped with (b) (4) following a (b) (4) disinfectant contact time; however, it is not effective in removing the disinfectant residue.
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

138
Form 483s Issued
16
483s converted to WL
152
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
20 May 2026
Strides Pharma Science Ltd.
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
01 May 2026
Alkem Laboratories Limited
Drugs
23 Mar 2026
Cerovene Inc.
Drugs
20 Mar 2026
Bora Pharmaceuticals Injectables Inc
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
Saleem A Akhtar
6
1
John Doe
5
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: The equipment cleaning process is fundamentally linked as residues indicate the cleaning process was inefficacious.
Excerpt: Residues were observed on the top of the HEPA filter housing...indicating a failure in the cleaning protocol.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Emcure Pharmaceuticals Limited
15 May 2026 Normal Justification: Residue accumulation on equipment directly implicates Equipment Cleaning processes.
Excerpt: Multiple locations within ISO 5 had residues on surfaces, indicating cleaning failures.
View Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions
Alkem Laboratories Limited
01 May 2026 Normal Justification: The presence of rust and water droplets suggests leaks and improper cleaning maintenance, impacting Equipment Cleaning processes.
Excerpt: Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination.
View Details
(Repeat) Equipment and utensils are not cleaned, maintained at appropriate intervals
Cerovene Inc.
23 Mar 2026 Normal Justification: The observation detailed cleaning issues directly related to improper equipment cleaning processes.
Excerpt: Presence of white caked residue in Capsule Machine ID and white powder inside validation locations.
View Details
Written procedures are not followed for the cleaning and maintenance of equipment
Bora Pharmaceuticals Injectables Inc
20 Mar 2026 Normal Justification: Observation directly relates to the ineffectiveness of equipment cleaning procedures, as disinfectant residue compromises equipment sterility.
Excerpt: The procedure indicates for equipment...to be wiped with (b) (4) following a (b) (4) disinfectant contact time; however, it is not effective in removing the disinfectant residue.
View Details

Frequently Asked Questions

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