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Sub System /
Water Quality Monitoring
Water Quality Monitoring
View Detailed Analysis

Analytics Overview

17
Form 483s Issued
3
483s converted to WL
18
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
01 Aug 2025
Not available
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
25 Mar 2024
Novo Nordisk A/S
Drugs
View Form 483
09 Nov 2023
Shilpa Medicare Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Ralph M Bernstein, Biologist
2
0
Zachary Kraus, Senior Research Scientist
2
0
Lindsey J Brown, Senior Microbiologist
2
0
Maxwell Korang-Yeboah, Senior Staff Fellow
2
0
Arsen Karapetyan
1
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your firm fails to assure that the water system used in production areas provides consistent and uncontaminated water for API synthesis.
Not available		 01 Aug 2025 Normal Justification: Water quality issues are directly tied to inadequate monitoring and failure to maintain acceptable TOC and microbiological limits per SOP.
Excerpt: The water used for the final rinsing of equipment involved in the synthesis of 'API C' exceeded Total Organic Carbon (TOC) limits.
View Details
I observed on 11/18/2024 an alert message displayed on HPLC ID #QC-400
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: Failure to obtain and check water quality documentation leads to uncontrolled quality risks.
Excerpt: suppliers did not provide you with any documentation not limited to certificate of analyses.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Monitoring lapses allowed leaks in the pharmaceutical water system, which is critical for contamination-free drug production.
Excerpt: I observed the (b) (4) and the (b) (4) holding tank 1 (b) (4) leaking with water puddles accumulated.
View Details
Insufficient information has been provided to demonstrate that the water and water used for
Novo Nordisk A/S		 25 Mar 2024 Normal Justification: The issue of microbial contamination directly relates to the adequacy of Water Quality Monitoring processes.
Excerpt: water used for drug substance (DS) purification is adequately controlled for total microbial counts.
View Details
The routine sample volume that is used to test for appropriate standards of quality
Novo Nordisk A/S		 25 Mar 2024 Normal Justification: Observation points to insufficient sample volumes for water quality, directly relating to water quality monitoring.
Excerpt: The routine sample volume ... is insufficient to be representative of the capacity of the water systems.
View Details

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Go back

Water Quality Monitoring

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

Water Quality Monitoring

Overview

17
Form 483s Issued
3
483s converted to WL
18
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
01 Aug 2025
Not available
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
25 Mar 2024
Novo Nordisk A/S
Drugs
View Form 483
09 Nov 2023
Shilpa Medicare Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Ralph M Bernstein, Biologist
2
0
Zachary Kraus, Senior Research Scientist
2
0
Lindsey J Brown, Senior Microbiologist
2
0
Maxwell Korang-Yeboah, Senior Staff Fellow
2
0
Arsen Karapetyan
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm fails to assure that the water system used in production areas provides consistent and uncontaminated water for API synthesis.
Not available		 01 Aug 2025 Normal Justification: Water quality issues are directly tied to inadequate monitoring and failure to maintain acceptable TOC and microbiological limits per SOP.
Excerpt: The water used for the final rinsing of equipment involved in the synthesis of 'API C' exceeded Total Organic Carbon (TOC) limits.
View Details
I observed on 11/18/2024 an alert message displayed on HPLC ID #QC-400
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: Failure to obtain and check water quality documentation leads to uncontrolled quality risks.
Excerpt: suppliers did not provide you with any documentation not limited to certificate of analyses.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Monitoring lapses allowed leaks in the pharmaceutical water system, which is critical for contamination-free drug production.
Excerpt: I observed the (b) (4) and the (b) (4) holding tank 1 (b) (4) leaking with water puddles accumulated.
View Details
Insufficient information has been provided to demonstrate that the water and water used for
Novo Nordisk A/S		 25 Mar 2024 Normal Justification: The issue of microbial contamination directly relates to the adequacy of Water Quality Monitoring processes.
Excerpt: water used for drug substance (DS) purification is adequately controlled for total microbial counts.
View Details
The routine sample volume that is used to test for appropriate standards of quality
Novo Nordisk A/S		 25 Mar 2024 Normal Justification: Observation points to insufficient sample volumes for water quality, directly relating to water quality monitoring.
Excerpt: The routine sample volume ... is insufficient to be representative of the capacity of the water systems.
View Details

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