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

Analytics Overview

20
Form 483s Issued
3
483s converted to WL
21
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
View Form 483
23 Mar 2026
Dr. J Skinclinic, Inc
Drugs
View Form 483
27 Feb 2026
Gasco Industrial Corp.
Drugs
View Form 483
02 May 2025
Concord Biotech Limited
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
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 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
Drug product component testing is deficient
Dr. J Skinclinic, Inc		 23 Mar 2026 Normal Justification: The observation explicitly mentions failures in conducting necessary tests and handling microbial limits in DI water, impacting water quality monitoring.
Excerpt: Your firm failed to provide documentation demonstrating that DI water does not require routine TOC, conductivity, and microbial testing.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products.
Gasco Industrial Corp.		 27 Feb 2026 Normal Justification: Unvalidated water system poses risks to product quality due to lack of specification compliance.
Excerpt: Controls have not been established to ensure (b) (4) system consistently produces pharmaceutical grade (b) (4).
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

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Get Real-time Insights: FDA 483s & Warning letters.
Uncover Trends: FDA Investigator profiles & Observations.
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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.

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Water Quality Monitoring

Overview

20
Form 483s Issued
3
483s converted to WL
21
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
08 Apr 2026
Pharmaneek Inc
Drugs
View Form 483
23 Mar 2026
Dr. J Skinclinic, Inc
Drugs
View Form 483
27 Feb 2026
Gasco Industrial Corp.
Drugs
View Form 483
02 May 2025
Concord Biotech Limited
Drugs
View Form 483
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
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 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
Drug product component testing is deficient
Dr. J Skinclinic, Inc		 23 Mar 2026 Normal Justification: The observation explicitly mentions failures in conducting necessary tests and handling microbial limits in DI water, impacting water quality monitoring.
Excerpt: Your firm failed to provide documentation demonstrating that DI water does not require routine TOC, conductivity, and microbial testing.
View Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products.
Gasco Industrial Corp.		 27 Feb 2026 Normal Justification: Unvalidated water system poses risks to product quality due to lack of specification compliance.
Excerpt: Controls have not been established to ensure (b) (4) system consistently produces pharmaceutical grade (b) (4).
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

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