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Sub System /
Laboratory Controls
Laboratory Controls
View Detailed Analysis

Analytics Overview

103
Form 483s Issued
23
483s converted to WL
135
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
View Form 483

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
Pratik S Upadhyay
6
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Observation highlights failures in control procedures impacting the validation of testing methodologies.
Excerpt: The test report was not captured in the software system. Your Quality Unit prepared the sample without documenting the failure.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation specifies failures in laboratory test procedures, directly related to Laboratory Controls.
Excerpt: The analyst was observed aspirating and dispensing lysate improperly, resulting in visible air bubbles and inaccurate volume transfer.
View Details
Established laboratory control mechanisms are not followed
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The observation highlights procedural non-compliance in laboratory settings affecting test outcomes, a core element of Laboratory Controls.
Excerpt: During the walkthrough inspection, multiple incidents were observed where employees were not following the written procedures.
View Details
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The observations highlight issues with maintaining accurate laboratory records and reviewing crucial data, both core to Laboratory Controls.
Excerpt: Your quality unit neither reviews nor prints these electronic records for review; documents signed with incorrect dates.
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

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Uncover Trends: FDA Investigator profiles & Observations.
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Go back

Laboratory Controls

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

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Laboratory Controls

Overview

103
Form 483s Issued
23
483s converted to WL
135
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
View Form 483
12 Dec 2025
Dr. Reddy's Laboratories Limited
Drugs
View Form 483

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
Pratik S Upadhyay
6
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Observation highlights failures in control procedures impacting the validation of testing methodologies.
Excerpt: The test report was not captured in the software system. Your Quality Unit prepared the sample without documenting the failure.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: The observation specifies failures in laboratory test procedures, directly related to Laboratory Controls.
Excerpt: The analyst was observed aspirating and dispensing lysate improperly, resulting in visible air bubbles and inaccurate volume transfer.
View Details
Established laboratory control mechanisms are not followed
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The observation highlights procedural non-compliance in laboratory settings affecting test outcomes, a core element of Laboratory Controls.
Excerpt: During the walkthrough inspection, multiple incidents were observed where employees were not following the written procedures.
View Details
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: The observations highlight issues with maintaining accurate laboratory records and reviewing crucial data, both core to Laboratory Controls.
Excerpt: Your quality unit neither reviews nor prints these electronic records for review; documents signed with incorrect dates.
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

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