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Sub System /
Sample Management
Sample Management
View Detailed Analysis

Analytics Overview

33
Form 483s Issued
8
483s converted to WL
35
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
27 Nov 2025
Gland Chemicals Private Limited
Drugs
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
11
0
Kiya Hamilton
11
0
David Carlson
11
0
Christy Osgood
11
0
Li Wang
11
0
TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: Sample Management is directly impacted due to improper collection and handling, leading to false data entries.
Excerpt: Microbiologists potentially falsified sample collection data and skipped primary gowning.
View Details
Established sampling plan and test procedures are not followed
Global Calcium Pvt. Limited
03 Feb 2026 Normal Justification: Sample management is linked as deficiencies were observed in documented sampling activities versus biometric access logs.
Excerpt: Water Sampling Register does not match biometric access logs, indicating procedural breakdown in sample management.
View Details
Established sampling plan and test procedures are not followed
Gland Chemicals Private Limited
27 Nov 2025 Normal Justification: Sample Management is impacted as discrepancies in presence documentation risk sample integrity and trustworthiness of data.
Excerpt: The biometric access control system does not show that employee entered the room during the sampling period.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited
21 Nov 2025 Normal Justification: Sample management issues are evident from missing reconciliation and unrecorded test details.
Excerpt: Quality unit has not reconciled all the received and tested samples with corresponding test results and reports.
View Details
Established sampling plans and test procedures are not followed and documented at the time of performance
Pharmathen International S.A.
21 Nov 2025 Normal Justification: Sample management involves tracking and documenting sampling activities as substantiated by observation in environmental sampling records.
Excerpt: Analysts were observed filling out the sampling information onto the paperwork during plate reading...
View Details

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Sample Management

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

Sample Management

Overview

33
Form 483s Issued
8
483s converted to WL
35
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
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
03 Feb 2026
Global Calcium Pvt. Limited
Drugs
27 Nov 2025
Gland Chemicals Private Limited
Drugs
21 Nov 2025
Lupin Limited
Drugs
21 Nov 2025
Pharmathen International S.A.
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
LaiMing Lee
11
0
Kiya Hamilton
11
0
David Carlson
11
0
Christy Osgood
11
0
Li Wang
11
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: Sample Management is directly impacted due to improper collection and handling, leading to false data entries.
Excerpt: Microbiologists potentially falsified sample collection data and skipped primary gowning.
View Details
Established sampling plan and test procedures are not followed
Global Calcium Pvt. Limited
03 Feb 2026 Normal Justification: Sample management is linked as deficiencies were observed in documented sampling activities versus biometric access logs.
Excerpt: Water Sampling Register does not match biometric access logs, indicating procedural breakdown in sample management.
View Details
Established sampling plan and test procedures are not followed
Gland Chemicals Private Limited
27 Nov 2025 Normal Justification: Sample Management is impacted as discrepancies in presence documentation risk sample integrity and trustworthiness of data.
Excerpt: The biometric access control system does not show that employee entered the room during the sampling period.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Lupin Limited
21 Nov 2025 Normal Justification: Sample management issues are evident from missing reconciliation and unrecorded test details.
Excerpt: Quality unit has not reconciled all the received and tested samples with corresponding test results and reports.
View Details
Established sampling plans and test procedures are not followed and documented at the time of performance
Pharmathen International S.A.
21 Nov 2025 Normal Justification: Sample management involves tracking and documenting sampling activities as substantiated by observation in environmental sampling records.
Excerpt: Analysts were observed filling out the sampling information onto the paperwork during plate reading...
View Details

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