Join us at the 11th Global
Pharmaceutical Quality Summit 2026
Join us at the 11th Global
Pharmaceutical Quality Summit 2026
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Sub System /
Quality Risk Management
Quality Risk Management
View Detailed Analysis

Analytics Overview

100
Form 483s Issued
16
483s converted to WL
120
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
29 Jun 2026
Not available
Drugs
01 May 2026
Mixlab WI LLC
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
03 Feb 2026
Global Calcium Pvt. Limited
Drugs

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
TITLE/ COMPANY Issue Date Status Details
Commitment to Quality in Pharmaceutical Development
Not available
29 Jun 2026 Normal Justification: Quality risk management is essential for the development program to prevent defects, errors, and ensure continual improvement.
Excerpt: Evaluate the pharmaceutical development program to determine the following: Resources are provided to perform activities...
View Details
Readiness for Commercial Manufacturing
Not available
29 Jun 2026 Normal Justification: Quality Risk Management is crucial for ensuring that a control strategy can mitigate potential issues in manufacturing.
Excerpt: Determine whether the establishment has a quality system designed to achieve sufficient control.
View Details
Copies of Approved or Indexed Products:
Mixlab WI LLC
01 May 2026 Normal Justification: This observation involves inadequate risk assessment and management practices, specifically with regards to ensuring the necessity and safety of compounded drugs.
Excerpt: Your records did not include the reasons why this prescription was compounded from BDS as opposed to using an FDA-approved product as the source of the active ingredient(s).
View 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

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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.

Quality Risk Management

Overview

100
Form 483s Issued
16
483s converted to WL
120
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
29 Jun 2026
Not available
Drugs
01 May 2026
Mixlab WI LLC
Drugs
20 Feb 2026
Maiva Pharma Private Limited
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
03 Feb 2026
Global Calcium Pvt. Limited
Drugs

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
Commitment to Quality in Pharmaceutical Development
Not available
29 Jun 2026 Normal Justification: Quality risk management is essential for the development program to prevent defects, errors, and ensure continual improvement.
Excerpt: Evaluate the pharmaceutical development program to determine the following: Resources are provided to perform activities...
View Details
Readiness for Commercial Manufacturing
Not available
29 Jun 2026 Normal Justification: Quality Risk Management is crucial for ensuring that a control strategy can mitigate potential issues in manufacturing.
Excerpt: Determine whether the establishment has a quality system designed to achieve sufficient control.
View Details
Copies of Approved or Indexed Products:
Mixlab WI LLC
01 May 2026 Normal Justification: This observation involves inadequate risk assessment and management practices, specifically with regards to ensuring the necessity and safety of compounded drugs.
Excerpt: Your records did not include the reasons why this prescription was compounded from BDS as opposed to using an FDA-approved product as the source of the active ingredient(s).
View 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

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