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

Analytics Overview

92
Form 483s Issued
16
483s converted to WL
115
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
21 Nov 2025
Lupin Limited
Drugs
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Christy Osgood
7
0
David Carlson
7
0
Kiya Hamilton
7
0
LaiMing Lee
7
0
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Lupin Limited
21 Nov 2025 Normal Justification: Risk assessments were cited but failed to adequately address cleaning deviations and impurity control.
Excerpt: The evaluation of Risk Assessment Number: QRM/25/L008/P/056/00 revealed procedural inadequacies.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specification
Empower Clinic Services, L.L.C. dba Empower Pharma
14 Nov 2025 Normal Justification: Management cited risk-based prioritization, yet lacked documentation for assessments and criteria.
Excerpt: Investigations are delayed due to onboarding of new writers, prioritized "by risk," yet no documented risk assessment provided.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Fresenius Kabi Compounding, LLC
06 Nov 2025 Normal Justification: The observation highlights a risk management failure in not addressing critical defects in CSP containers adequately.
Excerpt: Your firm released lots with port defects above %, such as vancomycin HCl 1 gram added to 250 mL 0.9% Sodium Chloride Injection USP IV Bag.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX
26 Sep 2025 Normal Justification: Using an unregistered lab without formal agreements points to deficiencies in assessing and managing quality risks.
Excerpt: Unregistered laboratory is not referenced in any of your Drug Master Files (DMF) filed with FDA.
View Details
During the Transition Period of Study RGB-14-101
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The process type 'Quality Risk Management' is linked to the issue as proper risk assessments could prevent or mitigate these adverse events.
Excerpt: Hypocalcemia adverse events reported...with the vast majority of these events mild in severity.
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

92
Form 483s Issued
16
483s converted to WL
115
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
21 Nov 2025
Lupin Limited
Drugs
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
06 Nov 2025
Fresenius Kabi Compounding, LLC
Drugs
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
23 Sep 2025
Hikma Pharmaceuticals USA Inc.
Drugs

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Lupin Limited
21 Nov 2025 Normal Justification: Risk assessments were cited but failed to adequately address cleaning deviations and impurity control.
Excerpt: The evaluation of Risk Assessment Number: QRM/25/L008/P/056/00 revealed procedural inadequacies.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specification
Empower Clinic Services, L.L.C. dba Empower Pharma
14 Nov 2025 Normal Justification: Management cited risk-based prioritization, yet lacked documentation for assessments and criteria.
Excerpt: Investigations are delayed due to onboarding of new writers, prioritized "by risk," yet no documented risk assessment provided.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Fresenius Kabi Compounding, LLC
06 Nov 2025 Normal Justification: The observation highlights a risk management failure in not addressing critical defects in CSP containers adequately.
Excerpt: Your firm released lots with port defects above %, such as vancomycin HCl 1 gram added to 250 mL 0.9% Sodium Chloride Injection USP IV Bag.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Hetero Labs Limited, Unit-IX
26 Sep 2025 Normal Justification: Using an unregistered lab without formal agreements points to deficiencies in assessing and managing quality risks.
Excerpt: Unregistered laboratory is not referenced in any of your Drug Master Files (DMF) filed with FDA.
View Details
During the Transition Period of Study RGB-14-101
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The process type 'Quality Risk Management' is linked to the issue as proper risk assessments could prevent or mitigate these adverse events.
Excerpt: Hypocalcemia adverse events reported...with the vast majority of these events mild in severity.
View Details

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