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Sub System /
Material Sampling and Testing
Material Sampling and Testing
View Detailed Analysis

Analytics Overview

42
Form 483s Issued
6
483s converted to WL
47
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 Aug 2025
Not available
Drugs
View Form 483
22 Oct 2024
Boothwyn Pharmacy LLC
Drugs
View Form 483
11 Oct 2024
Charles River Laboratories, Inc
Drugs
View Form 483
02 Aug 2024
ProRx LLC
Drugs
View Form 483
View Warning Letter
26 Jul 2024
Nubratori, Inc
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christopher R Czajka
5
0
Arsen Karapetyan
3
0
Cynthia Jim, Consumer Safety Officer
2
0
Anastasia M Shields
2
2
Julia N Alvarez
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The Quality Control laboratory did not perform necessary identity tests on incoming raw materials before release for production use.
Not available		 01 Aug 2025 Normal Justification: The observation highlights a breach in the 'Material Sampling and Testing' where SOP protocols for identity testing were ignored.
Excerpt: This contradicts your firm’s SOP 'Material Identity Testing Protocol -10.'
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
Boothwyn Pharmacy LLC		 22 Oct 2024 Normal Justification: The observation highlights the firm's reliance on supplier COAs without independent verification, a core function of material sampling and testing.
Excerpt: Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications.
View Details
Your procedures for testing and qualifying raw materials used in the manufacture of (b) (4) are deficient
Charles River Laboratories, Inc		 11 Oct 2024 Normal Justification: The failure to conduct (b)(4) testing on incoming raw materials relates directly to the inadequacy of the material sampling and testing process—this area governs how pharma manufacturers test and approve incoming raw materials to ensure they meet all specifications prior to use.
Excerpt: (b) (4) used in the (b) (4) manufacturing process are not currently tested for (b)(4) after receipt from the supplier.
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
ProRx LLC		 02 Aug 2024 Normal Justification: The observation directly mentions the lack of identity testing and validation of supplier's test results.
Excerpt: without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
View Details
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
Nubratori, Inc		 26 Jul 2024 Normal Justification: The observation highlights the failure to conduct necessary testing, directly associated with Material Sampling and Testing processes.
Excerpt: Your firm failed to perform microbial and endotoxin testing on all lots of the following Bulk Drug Substances (BDS):...
View Details

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Go back

Material Sampling and 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

Material Sampling and Testing

Overview

42
Form 483s Issued
6
483s converted to WL
47
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 Aug 2025
Not available
Drugs
View Form 483
22 Oct 2024
Boothwyn Pharmacy LLC
Drugs
View Form 483
11 Oct 2024
Charles River Laboratories, Inc
Drugs
View Form 483
02 Aug 2024
ProRx LLC
Drugs
View Form 483
View Warning Letter
26 Jul 2024
Nubratori, Inc
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christopher R Czajka
5
0
Arsen Karapetyan
3
0
Cynthia Jim, Consumer Safety Officer
2
0
Anastasia M Shields
2
2
Julia N Alvarez
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The Quality Control laboratory did not perform necessary identity tests on incoming raw materials before release for production use.
Not available		 01 Aug 2025 Normal Justification: The observation highlights a breach in the 'Material Sampling and Testing' where SOP protocols for identity testing were ignored.
Excerpt: This contradicts your firm’s SOP 'Material Identity Testing Protocol -10.'
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
Boothwyn Pharmacy LLC		 22 Oct 2024 Normal Justification: The observation highlights the firm's reliance on supplier COAs without independent verification, a core function of material sampling and testing.
Excerpt: Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications.
View Details
Your procedures for testing and qualifying raw materials used in the manufacture of (b) (4) are deficient
Charles River Laboratories, Inc		 11 Oct 2024 Normal Justification: The failure to conduct (b)(4) testing on incoming raw materials relates directly to the inadequacy of the material sampling and testing process—this area governs how pharma manufacturers test and approve incoming raw materials to ensure they meet all specifications prior to use.
Excerpt: (b) (4) used in the (b) (4) manufacturing process are not currently tested for (b)(4) after receipt from the supplier.
View Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
ProRx LLC		 02 Aug 2024 Normal Justification: The observation directly mentions the lack of identity testing and validation of supplier's test results.
Excerpt: without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
View Details
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
Nubratori, Inc		 26 Jul 2024 Normal Justification: The observation highlights the failure to conduct necessary testing, directly associated with Material Sampling and Testing processes.
Excerpt: Your firm failed to perform microbial and endotoxin testing on all lots of the following Bulk Drug Substances (BDS):...
View Details

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