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Sub System /
Sample Testing
Sample Testing
View Detailed Analysis

Analytics Overview

103
Form 483s Issued
13
483s converted to WL
118
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
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
27 Mar 2026
Bentley Laboratories LLC
Drugs
View Form 483
23 Mar 2026
Dr. J Skinclinic, Inc
Drugs
View Form 483
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
18 Feb 2026
Gilead Sciences, Inc.
Drugs
View Form 483

Top Investigators

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

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications
Bentley Laboratories LLC		 27 Mar 2026 Normal Justification: Sample testing is directly related to ensuring that drug products meet safety standards, including absence of harmful microbes.
Excerpt: Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance...
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Dr. J Skinclinic, Inc		 23 Mar 2026 Normal Justification: Sample Testing is directly compromised as no pre-distribution testing is conducted on API bulk products.
Excerpt: Your firm does not perform active pharmaceutical ingredient (API) ID and strength testing on bulk products...
View Details
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Dr. J Skinclinic, Inc		 23 Mar 2026 Normal Justification: Sample Testing is relevant as pre-release API tests were neglected, affecting product quality assurance.
Excerpt: Your firm failed to perform active pharmaceutical ingredient (API) identity and strength testing on bulk products prior to release.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Issues were directly linked with the handling and accuracy assurance of volumes during Sample Testing.
Excerpt: Lower volumes of lysate may decrease endotoxin test sensitivity and result in false negatives.
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.

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Sample Testing

Overview

103
Form 483s Issued
13
483s converted to WL
118
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
01 May 2026
Alkem Laboratories Limited
Drugs
View Form 483
27 Mar 2026
Bentley Laboratories LLC
Drugs
View Form 483
23 Mar 2026
Dr. J Skinclinic, Inc
Drugs
View Form 483
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
18 Feb 2026
Gilead Sciences, Inc.
Drugs
View Form 483

Top FDA Investigators

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

Key Observations

TITLE/ COMPANY Issue Date Status 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications
Bentley Laboratories LLC		 27 Mar 2026 Normal Justification: Sample testing is directly related to ensuring that drug products meet safety standards, including absence of harmful microbes.
Excerpt: Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance...
View Details
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Dr. J Skinclinic, Inc		 23 Mar 2026 Normal Justification: Sample Testing is directly compromised as no pre-distribution testing is conducted on API bulk products.
Excerpt: Your firm does not perform active pharmaceutical ingredient (API) ID and strength testing on bulk products...
View Details
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Dr. J Skinclinic, Inc		 23 Mar 2026 Normal Justification: Sample Testing is relevant as pre-release API tests were neglected, affecting product quality assurance.
Excerpt: Your firm failed to perform active pharmaceutical ingredient (API) identity and strength testing on bulk products prior to release.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Issues were directly linked with the handling and accuracy assurance of volumes during Sample Testing.
Excerpt: Lower volumes of lysate may decrease endotoxin test sensitivity and result in false negatives.
View Details

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