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Sub System /
Quality Risk Management
Quality Risk Management
View Detailed Analysis

Analytics Overview

68
Form 483s Issued
12
483s converted to WL
83
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
09 May 2025
LEESAR, INC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
28 Feb 2025
Palmetto Isotopes, LLC
Drugs
View Form 483
21 Feb 2025
Meds For Vets
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
6
2
Ruben C Quintana
4
0
Justin A Boyd
4
2
Nibin Varghese
4
0
Taichun Qin
4
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
LEESAR, INC		 09 May 2025 Normal Justification: Outdated Quality Assurance Program procedure directly impacts risk management practices by not reflecting actual operations.
Excerpt: Program has not been reviewed or updated since 2020 and does not reflect current operations at your firm.
View Details
The statistical quality control criteria fail to include appropriate rejection levels.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Quality Risk Management is responsible for ensuring that defect classification and rejection criteria are scientifically justified.
Excerpt: The statistical quality control criteria fail to include appropriate rejection levels. CSP Defect Evaluation used for initial defect classification does not include scientific justification.
View Details
Inadequate routine environmental monitoring in the ISO 5 area.
Palmetto Isotopes, LLC		 28 Feb 2025 Normal Justification: Risk management processes should identify and mitigate risks from lack of viable monitoring in sterile zones.
Excerpt: Environmental monitoring of the nuclear lab used for processing radiopharmaceuticals is inadequate.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic and sterilization process.
Meds For Vets		 21 Feb 2025 Normal Justification: Without a structured risk management system, potential hazards may go unchecked, compromising product quality and safety.
Excerpt: The air pressure gauge used to perform post (b) (4) (b) (4) ) of all (b) (4) has never been calibrated.
View Details
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: The observation directly reflects inadequate quality risk management, as risks associated with discrepancies and cross-batch issues remain unexplored.
Excerpt: The investigation failed to perform any identification of the foreign matter or take any pictures.
View Details

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Go back

Quality Risk Management

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

Quality Risk Management

Overview

68
Form 483s Issued
12
483s converted to WL
83
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
09 May 2025
LEESAR, INC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
28 Feb 2025
Palmetto Isotopes, LLC
Drugs
View Form 483
21 Feb 2025
Meds For Vets
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
6
2
Ruben C Quintana
4
0
Justin A Boyd
4
2
Nibin Varghese
4
0
Taichun Qin
4
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
LEESAR, INC		 09 May 2025 Normal Justification: Outdated Quality Assurance Program procedure directly impacts risk management practices by not reflecting actual operations.
Excerpt: Program has not been reviewed or updated since 2020 and does not reflect current operations at your firm.
View Details
The statistical quality control criteria fail to include appropriate rejection levels.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Quality Risk Management is responsible for ensuring that defect classification and rejection criteria are scientifically justified.
Excerpt: The statistical quality control criteria fail to include appropriate rejection levels. CSP Defect Evaluation used for initial defect classification does not include scientific justification.
View Details
Inadequate routine environmental monitoring in the ISO 5 area.
Palmetto Isotopes, LLC		 28 Feb 2025 Normal Justification: Risk management processes should identify and mitigate risks from lack of viable monitoring in sterile zones.
Excerpt: Environmental monitoring of the nuclear lab used for processing radiopharmaceuticals is inadequate.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic and sterilization process.
Meds For Vets		 21 Feb 2025 Normal Justification: Without a structured risk management system, potential hazards may go unchecked, compromising product quality and safety.
Excerpt: The air pressure gauge used to perform post (b) (4) (b) (4) ) of all (b) (4) has never been calibrated.
View Details
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: The observation directly reflects inadequate quality risk management, as risks associated with discrepancies and cross-batch issues remain unexplored.
Excerpt: The investigation failed to perform any identification of the foreign matter or take any pictures.
View Details

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