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Sub System /
Laboratory Controls
Laboratory Controls
View Detailed Analysis

Analytics Overview

99
Form 483s Issued
23
483s converted to WL
127
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs
26 Sep 2025
Baxter Onocology GmbH
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
24
6
Justin A Boyd
14
4
Anastasia M Shields
10
4
Patty P Kaewussdangkul
8
3
Steven A Brettler
5
4
TITLE/ COMPANY Issue Date Status Details
Established laboratory control mechanisms are not followed
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: Involves overall Laboratory Controls as the oversight of laboratory practices and error rectifications was insufficient.
Excerpt: The firm invalidated the initial results and concluded...without adequate scientific justification.
View Details
Test procedures relative to appropriate laboratory testing for pyrogens are not followed
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: The Laboratory Controls process type is implicated as the observed practice deviates from established protocols dictating handling of test samples.
Excerpt: The SOP entitled, 'HANDING OF LAL REAGENTS AND BACTERIAL ENDOTOXIN TESTING BY GEL-CLOT TECHNIQUE' states that microbiologists are to 'gently mix the tubes' prior to incubation.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination
Dr. Reddy's Laboratories Limited
12 Dec 2025 Normal Justification: Laboratory Controls are directly linked as discrepancy in HPLC assay validation impacts the reliability of laboratory outcomes.
Excerpt: Section 5.10.6 of your procedure, SOP-GLOB-QC-0085 requires (4) measurements from each preparation for assay test methods by HPLC.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Pharmathen International S.A.
21 Nov 2025 Normal Justification: The issue directly concerns laboratory controls and sterility testing methods, which are pivotal for assuring drug product conformity.
Excerpt: The method validation did not assess techniques to ensure the product could be effectively dispersed.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Lupin Limited
21 Nov 2025 Normal Justification: The observation highlights a failure in laboratory controls due to unreliable swab sample analysis methods.
Excerpt: Analytical test procedures for swab sample analyses are not reliable to determine the level of active and degradant residual materials.
View Details

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Laboratory Controls

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

Laboratory Controls

Overview

99
Form 483s Issued
23
483s converted to WL
127
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
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs
26 Sep 2025
Baxter Onocology GmbH
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
24
6
Justin A Boyd
14
4
Anastasia M Shields
10
4
Patty P Kaewussdangkul
8
3
Steven A Brettler
5
4

Key Observations

TITLE/ COMPANY Issue Date Status Details
Established laboratory control mechanisms are not followed
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: Involves overall Laboratory Controls as the oversight of laboratory practices and error rectifications was insufficient.
Excerpt: The firm invalidated the initial results and concluded...without adequate scientific justification.
View Details
Test procedures relative to appropriate laboratory testing for pyrogens are not followed
Eugia Pharma Specialities Limited
06 Feb 2026 Normal Justification: The Laboratory Controls process type is implicated as the observed practice deviates from established protocols dictating handling of test samples.
Excerpt: The SOP entitled, 'HANDING OF LAL REAGENTS AND BACTERIAL ENDOTOXIN TESTING BY GEL-CLOT TECHNIQUE' states that microbiologists are to 'gently mix the tubes' prior to incubation.
View Details
Testing and release of drug product for distribution do not include appropriate laboratory determination
Dr. Reddy's Laboratories Limited
12 Dec 2025 Normal Justification: Laboratory Controls are directly linked as discrepancy in HPLC assay validation impacts the reliability of laboratory outcomes.
Excerpt: Section 5.10.6 of your procedure, SOP-GLOB-QC-0085 requires (4) measurements from each preparation for assay test methods by HPLC.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Pharmathen International S.A.
21 Nov 2025 Normal Justification: The issue directly concerns laboratory controls and sterility testing methods, which are pivotal for assuring drug product conformity.
Excerpt: The method validation did not assess techniques to ensure the product could be effectively dispersed.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Lupin Limited
21 Nov 2025 Normal Justification: The observation highlights a failure in laboratory controls due to unreliable swab sample analysis methods.
Excerpt: Analytical test procedures for swab sample analyses are not reliable to determine the level of active and degradant residual materials.
View Details

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