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Pharmaceutical Quality Summit 2026
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Pharmaceutical Quality Summit 2026
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Sub System /
Sample Testing

Analytics Overview

126
Form 483s Issued
13
483s converted to WL
142
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
03 Sep 2026
RC Outsourcing, LLC
Drugs
01 May 2026
Alkem Laboratories Limited
Drugs
14 Apr 2026
Frontage Laboratories, Inc.
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
13
0
Christy Osgood
13
0
Kiya Hamilton
13
0
David Carlson
13
0
Li Wang
13
0
TITLE/ COMPANY Issue Date Status Details
The establishment failed to thoroughly review any unexplained discrepancy in batch production records.
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: The lack of actions on sterility test failures directly relates to inadequacies in sample testing processes.
Excerpt: No documented investigation or corrective actions taken concerning the out-of-specification results for sterility testing.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Testing limitations directly affect sample testing processes by preventing accurate measurement of product quality.
Excerpt: Your firm releases this product using a subvisible particulate matter specification of (b) (4).
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Alkem Laboratories Limited
01 May 2026 Normal Justification: Observation demonstrates procedural shortcuts in Sample Testing during UV Spectrometry analyses.
Excerpt: No justification provided by your QC Analyst about how testing of multiple samples was completed in the shorter time.
View Details
Written records of investigations into unexplained discrepancies
Frontage Laboratories, Inc.
14 Apr 2026 Normal Justification: The high variability observed during retesting directly implicates issues with the sample testing process.
Excerpt: No justifications were provided for the high (~6%) testing variabilities observed during the retesting.
View Details
Written records of investigations into unexplained discrepancies
Frontage Laboratories, Inc.
14 Apr 2026 Normal Justification: The high variability observed during retesting directly implicates issues with the sample testing process.
Excerpt: No justifications were provided for the high (~6%) testing variabilities observed during the retesting.
View Details

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Sample Testing

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Sample Testing

Overview

126
Form 483s Issued
13
483s converted to WL
142
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
17 Sep 2026
Ultragenyx Pharmaceutical Inc.
Drugs
03 Sep 2026
RC Outsourcing, LLC
Drugs
01 May 2026
Alkem Laboratories Limited
Drugs
14 Apr 2026
Frontage Laboratories, Inc.
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
13
0
Christy Osgood
13
0
Kiya Hamilton
13
0
David Carlson
13
0
Li Wang
13
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The establishment failed to thoroughly review any unexplained discrepancy in batch production records.
Ultragenyx Pharmaceutical Inc.
17 Sep 2026 Normal Justification: The lack of actions on sterility test failures directly relates to inadequacies in sample testing processes.
Excerpt: No documented investigation or corrective actions taken concerning the out-of-specification results for sterility testing.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications
RC Outsourcing, LLC
03 Sep 2026 Normal Justification: Testing limitations directly affect sample testing processes by preventing accurate measurement of product quality.
Excerpt: Your firm releases this product using a subvisible particulate matter specification of (b) (4).
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Alkem Laboratories Limited
01 May 2026 Normal Justification: Observation demonstrates procedural shortcuts in Sample Testing during UV Spectrometry analyses.
Excerpt: No justification provided by your QC Analyst about how testing of multiple samples was completed in the shorter time.
View Details
Written records of investigations into unexplained discrepancies
Frontage Laboratories, Inc.
14 Apr 2026 Normal Justification: The high variability observed during retesting directly implicates issues with the sample testing process.
Excerpt: No justifications were provided for the high (~6%) testing variabilities observed during the retesting.
View Details
Written records of investigations into unexplained discrepancies
Frontage Laboratories, Inc.
14 Apr 2026 Normal Justification: The high variability observed during retesting directly implicates issues with the sample testing process.
Excerpt: No justifications were provided for the high (~6%) testing variabilities observed during the retesting.
View Details

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Related Resources

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