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

Analytics Overview

49
Form 483s Issued
6
483s converted to WL
55
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
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Christopher R Czajka
5
0
Arsen Karapetyan
5
0
Cynthia Jim, Consumer Safety Officer
2
0
Anastasia M Shields
2
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written procedures are not followed for the sampling of drug substance and excipients.
Dr. Reddy's Laboratories Limited		 12 Dec 2025 Normal Justification: The observation highlights failures in the sampling process which directly impacts the quality and purity of raw materials.
Excerpt: Your sampling practices are not scientifically sound and appropriate to ensure that your raw materials conform to established standards.
View Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: The observation notes missing identity tests of components, which are crucial for the Material Sampling and Testing process.
Excerpt: Your firm failed to conduct an identity test on each shipment of each lot of components used.
View Details
Certificates of analysis from raw material suppliers are accepted in lieu of testing
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: This process type is affected due to the lack of testing actual samples for identity and purity.
Excerpt: No identity or microbiological testing was performed to ensure conformance to standards.
View Details
Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw materials and APIs meet accepted quality standards
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Observation indicates a direct failure in assessing and implementing proper sampling and testing for microbial contamination.
Excerpt: Your firm failed to perform an adequate assessment to determine whether microbial testing is required for the API.
View Details
The number of containers to be sampled is not based upon appropriate criteria.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: Observation directly addresses issues with sampling procedures and representativeness, a core aspect of Material Sampling and Testing.
Excerpt: The current sampling procedure does not provide assurance that samples are representative of the entire lot when multiple containers are received.
View Details

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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.

Share

Material Sampling and Testing

Overview

49
Form 483s Issued
6
483s converted to WL
55
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
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
View Form 483
14 Nov 2025
Empower Clinic Services, L.L.C. dba Empower Pharma
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
07 Aug 2025
Sumitomo Pharma Co., Ltd.
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Christopher R Czajka
5
0
Arsen Karapetyan
5
0
Cynthia Jim, Consumer Safety Officer
2
0
Anastasia M Shields
2
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written procedures are not followed for the sampling of drug substance and excipients.
Dr. Reddy's Laboratories Limited		 12 Dec 2025 Normal Justification: The observation highlights failures in the sampling process which directly impacts the quality and purity of raw materials.
Excerpt: Your sampling practices are not scientifically sound and appropriate to ensure that your raw materials conform to established standards.
View Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.
Empower Clinic Services, L.L.C. dba Empower Pharma		 14 Nov 2025 Normal Justification: The observation notes missing identity tests of components, which are crucial for the Material Sampling and Testing process.
Excerpt: Your firm failed to conduct an identity test on each shipment of each lot of components used.
View Details
Certificates of analysis from raw material suppliers are accepted in lieu of testing
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: This process type is affected due to the lack of testing actual samples for identity and purity.
Excerpt: No identity or microbiological testing was performed to ensure conformance to standards.
View Details
Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw materials and APIs meet accepted quality standards
Dr. Reddy's Laboratories (EU) Ltd.		 05 Sep 2025 Normal Justification: Observation indicates a direct failure in assessing and implementing proper sampling and testing for microbial contamination.
Excerpt: Your firm failed to perform an adequate assessment to determine whether microbial testing is required for the API.
View Details
The number of containers to be sampled is not based upon appropriate criteria.
Sumitomo Pharma Co., Ltd.		 07 Aug 2025 Normal Justification: Observation directly addresses issues with sampling procedures and representativeness, a core aspect of Material Sampling and Testing.
Excerpt: The current sampling procedure does not provide assurance that samples are representative of the entire lot when multiple containers are received.
View Details

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