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

Analytics Overview

18
Form 483s Issued
3
483s converted to WL
19
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
08 Apr 2026
Pharmaneek Inc
Drugs
02 May 2025
Concord Biotech Limited
Drugs
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
25 Mar 2024
Novo Nordisk A/S
Drugs

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
TITLE/ COMPANY Issue Date Status Details
Your firm failed to confirm that the quality of water was suitable for its intended use in the production
Pharmaneek Inc
08 Apr 2026 Normal Justification: Water Quality Monitoring is essential as the observation highlights failure in confirming water meets USP standards.
Excerpt: No data to demonstrate that the water used met the specifications for (b) (4) Water USP.
View 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
Failure to ensure that water used in the manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts
Concord Biotech Limited
02 May 2025 Normal Justification: Water Quality Monitoring is directly linked to maintaining water safety standards crucial for sterile drugs.
Excerpt: Your firm failed to test the or endotoxins.
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

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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.

Water Quality Monitoring

Overview

18
Form 483s Issued
3
483s converted to WL
19
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
08 Apr 2026
Pharmaneek Inc
Drugs
02 May 2025
Concord Biotech Limited
Drugs
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
25 Mar 2024
Novo Nordisk A/S
Drugs

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 failed to confirm that the quality of water was suitable for its intended use in the production
Pharmaneek Inc
08 Apr 2026 Normal Justification: Water Quality Monitoring is essential as the observation highlights failure in confirming water meets USP standards.
Excerpt: No data to demonstrate that the water used met the specifications for (b) (4) Water USP.
View 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
Failure to ensure that water used in the manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts
Concord Biotech Limited
02 May 2025 Normal Justification: Water Quality Monitoring is directly linked to maintaining water safety standards crucial for sterile drugs.
Excerpt: Your firm failed to test the or endotoxins.
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

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