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

Analytics Overview

95
Form 483s Issued
16
483s converted to WL
114
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 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
David Carlson
7
0
Christy Osgood
7
0
Kiya Hamilton
7
0
LaiMing Lee
7
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The risk management flaws directly relate to inappropriate adjustments of regulatory practices.
Excerpt: The quality risk assessment is inadequate in that the detectability score was assigned a value of (b) (4).
View Details
Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The absence of risk assessments and mitigation plans indicates flaws in the Quality Risk Management process.
Excerpt: No detailed risk assessment was performed to analyze potential failure modes.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Quality Risk Management is involved as inadequate risks were evaluated and controlled, resulting in data manipulation.
Excerpt: Your Quality Unit lack an adequate oversight in ensuring the integrity of testing data.
View Details
The responsibilities of your Quality Unit are not fully followed
Global Calcium Pvt. Limited		 03 Feb 2026 Normal Justification: Risk management deficiencies, as incorrect assessments impacted data integrity evaluation and actions.
Excerpt: Your Quality Unit followed the statistical approach of (b)(4) to evaluate the production records.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: A lack of risk assessment dilutes the efficacy of contamination controls and undermines process robustness.
Excerpt: Your Quality Unit did not conduct a formal, documented risk assessment to determine contamination risk.
View Details

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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.

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Quality Risk Management

Overview

95
Form 483s Issued
16
483s converted to WL
114
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483
27 Nov 2025
Gland Chemicals Private Limited
Drugs
View Form 483
21 Nov 2025
Lupin Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
David Carlson
7
0
Christy Osgood
7
0
Kiya Hamilton
7
0
LaiMing Lee
7
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The risk management flaws directly relate to inappropriate adjustments of regulatory practices.
Excerpt: The quality risk assessment is inadequate in that the detectability score was assigned a value of (b) (4).
View Details
Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The absence of risk assessments and mitigation plans indicates flaws in the Quality Risk Management process.
Excerpt: No detailed risk assessment was performed to analyze potential failure modes.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Quality Risk Management is involved as inadequate risks were evaluated and controlled, resulting in data manipulation.
Excerpt: Your Quality Unit lack an adequate oversight in ensuring the integrity of testing data.
View Details
The responsibilities of your Quality Unit are not fully followed
Global Calcium Pvt. Limited		 03 Feb 2026 Normal Justification: Risk management deficiencies, as incorrect assessments impacted data integrity evaluation and actions.
Excerpt: Your Quality Unit followed the statistical approach of (b)(4) to evaluate the production records.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process
Gland Chemicals Private Limited		 27 Nov 2025 Normal Justification: A lack of risk assessment dilutes the efficacy of contamination controls and undermines process robustness.
Excerpt: Your Quality Unit did not conduct a formal, documented risk assessment to determine contamination risk.
View Details

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