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

Analytics Overview

67
Form 483s Issued
6
483s converted to WL
78
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
07 Aug 2026
Neeyaan LLC
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Arsen Karapetyan
5
0
Christopher R Czajka
5
0
Muna Algharibeh
3
0
Andrew Le
2
0
TITLE/ COMPANY Issue Date Status Details
Your firm's quality control unit failed to exercise its responsibility
Neeyaan LLC
07 Aug 2026 Normal Justification: Traceability from raw materials to finished products was compromised due to inadequate procedures.
Excerpt: Establishment of written procedures to ensure traceability of raw materials and in-process materials.
View Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications
Neeyaan LLC
07 Aug 2026 Normal Justification: Material Sampling and Testing processes are directly implicated as testing and verification of raw materials were inadequate.
Excerpt: You failed to test samples of each component for identity...relying on supplier's certificate of analysis without establishing reliability.
View Details
Each component is not tested for conformity with all written specifications for purity, strength, and quality.
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Material Sampling and Testing relates to the testing procedures that were not adhered to as per the observation.
Excerpt: Your firm failed to perform (4) testing, including the limit test for (b)(4), on (b)(4) each shipment of each lot of high-risk drug components.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Emcure Pharmaceuticals Limited
15 May 2026 Normal Justification: Material Sampling and Testing directly influences how raw materials are verified for compliance per observation details.
Excerpt: Your firm does not test the following raw materials for the limit of (b)(4), on each container individually...
View Details
The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.
Novel Laboratories, Inc. d.b.a Lupin
17 Apr 2026 Normal Justification: The observation specifically points out inadequacies in sampling procedures (SOP No. NL-QA-017.12) for high-risk components, linking to sampling and testing processes.
Excerpt: The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.
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.

Material Sampling and Testing

Overview

67
Form 483s Issued
6
483s converted to WL
78
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
07 Aug 2026
Neeyaan LLC
Drugs
20 May 2026
Strides Pharma Science Ltd.
Drugs
15 May 2026
Emcure Pharmaceuticals Limited
Drugs
17 Apr 2026
Novel Laboratories, Inc. d.b.a Lupin
Drugs
27 Mar 2026
Bentley Laboratories LLC
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
6
0
Arsen Karapetyan
5
0
Christopher R Czajka
5
0
Muna Algharibeh
3
0
Andrew Le
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm's quality control unit failed to exercise its responsibility
Neeyaan LLC
07 Aug 2026 Normal Justification: Traceability from raw materials to finished products was compromised due to inadequate procedures.
Excerpt: Establishment of written procedures to ensure traceability of raw materials and in-process materials.
View Details
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications
Neeyaan LLC
07 Aug 2026 Normal Justification: Material Sampling and Testing processes are directly implicated as testing and verification of raw materials were inadequate.
Excerpt: You failed to test samples of each component for identity...relying on supplier's certificate of analysis without establishing reliability.
View Details
Each component is not tested for conformity with all written specifications for purity, strength, and quality.
Strides Pharma Science Ltd.
20 May 2026 Normal Justification: Material Sampling and Testing relates to the testing procedures that were not adhered to as per the observation.
Excerpt: Your firm failed to perform (4) testing, including the limit test for (b)(4), on (b)(4) each shipment of each lot of high-risk drug components.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Emcure Pharmaceuticals Limited
15 May 2026 Normal Justification: Material Sampling and Testing directly influences how raw materials are verified for compliance per observation details.
Excerpt: Your firm does not test the following raw materials for the limit of (b)(4), on each container individually...
View Details
The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.
Novel Laboratories, Inc. d.b.a Lupin
17 Apr 2026 Normal Justification: The observation specifically points out inadequacies in sampling procedures (SOP No. NL-QA-017.12) for high-risk components, linking to sampling and testing processes.
Excerpt: The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.
View Details

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