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Sub System /
Sample Testing
Sample Testing
View Detailed Analysis

Analytics Overview

60
Form 483s Issued
12
483s converted to WL
70
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
21 Feb 2025
Meds For Vets
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christopher R Czajka
5
0
Taichun Qin
4
0
Justin A Boyd
4
2
Julia N Alvarez
3
0
Crystal Monroy
3
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Testing and release of drug product for distribution
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Sample Testing is directly connected as improper testing resulted in undetected particulates.
Excerpt: does not provide adequate contrast required to ensure that particles... can be visually detected.
View Details
Examination and testing of samples is not done to assure that in-process materials conform to specifications.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: The issue stems from insufficient sample testing to verify compliance with specified critical process parameters.
Excerpt: Examination and testing of samples is not done to assure that in-process materials conform to specifications.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance
BSO, LLC		 27 Jun 2025 Normal Justification: Sample Testing process is linked as dissolution testing is critical for confirming product safety and efficacy before release.
Excerpt: you do not perform dissolution testing as part of batch release.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Sample Testing processes are inadequate as evidenced by missing original samples and improper re-testing that led to questionable batch releases.
Excerpt: Your investigation could not identify a root cause in the laboratory, and therefore, continue to repeat the test with other bottles.
View Details
The accuracy, specificity and reproducibility of test methods have not been established.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Related to Sample Testing because the observation involved issues with multiple retests without proper documentation.
Excerpt: The raw data sheets show that the method suitability testing was retested multiple times.
View Details

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Go back

Sample Testing

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

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Sample Testing

Overview

60
Form 483s Issued
12
483s converted to WL
70
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
04 Apr 2025
QuVa Pharma, Inc.
Drugs
View Form 483
21 Feb 2025
Meds For Vets
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christopher R Czajka
5
0
Taichun Qin
4
0
Justin A Boyd
4
2
Julia N Alvarez
3
0
Crystal Monroy
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Testing and release of drug product for distribution
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Sample Testing is directly connected as improper testing resulted in undetected particulates.
Excerpt: does not provide adequate contrast required to ensure that particles... can be visually detected.
View Details
Examination and testing of samples is not done to assure that in-process materials conform to specifications.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: The issue stems from insufficient sample testing to verify compliance with specified critical process parameters.
Excerpt: Examination and testing of samples is not done to assure that in-process materials conform to specifications.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance
BSO, LLC		 27 Jun 2025 Normal Justification: Sample Testing process is linked as dissolution testing is critical for confirming product safety and efficacy before release.
Excerpt: you do not perform dissolution testing as part of batch release.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Sample Testing processes are inadequate as evidenced by missing original samples and improper re-testing that led to questionable batch releases.
Excerpt: Your investigation could not identify a root cause in the laboratory, and therefore, continue to repeat the test with other bottles.
View Details
The accuracy, specificity and reproducibility of test methods have not been established.
QuVa Pharma, Inc.		 04 Apr 2025 Normal Justification: Related to Sample Testing because the observation involved issues with multiple retests without proper documentation.
Excerpt: The raw data sheets show that the method suitability testing was retested multiple times.
View Details

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