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Sub System /
Sample Management
Sample Management
View Detailed Analysis

Analytics Overview

20
Form 483s Issued
6
483s converted to WL
22
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
16 May 2025
STAQ Pharma of Ohio, LLC
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483
06 Jan 2025
Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Teresa I Navas
4
2
Justin A Boyd
4
3
Xiaohui Shen
3
1
Mary-Jeanet Mcgarry
2
2
June P Page
2
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
STAQ Pharma of Ohio, LLC		 16 May 2025 Normal Justification: Effective sample management is critical as proper sampling plans are essential to categorize and manage defect analysis.
Excerpt: The acceptance sampling inspection governed by procedure SOP-0052 does not clearly define reinspection parameters.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Sample Management is affected due to improper vial handling, affecting the quality of inspections.
Excerpt: Follow SOP2004 Visual Inspection by shaking and inverting the vials too forcibly.
View Details
Batch production and control records do not include in-process and laboratory control results for each batch of drug product produced.
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Sample Management is implicated due to the need for comprehensive documentation of inspection results for decision-making.
Excerpt: You did not document complete results of 100% visual inspection...
View Details
In-process samples are not representative
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Sample Management is directly involved since it oversees the method and quality of in-process sample collection.
Excerpt: There is no assurance that the sampling approach is a statistically representative of each product and each lot.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Wells Pharma of Houston LLC		 28 Mar 2025 Normal Justification: Sample Management is impacted by the failures in the visual inspection process, affecting defect detection.
Excerpt: Your firm's visual inspection training program governed by SOP HOU-QA-006 is deficient.
View Details

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Go back

Sample Management

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

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Sample Management

Overview

20
Form 483s Issued
6
483s converted to WL
22
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
16 May 2025
STAQ Pharma of Ohio, LLC
Drugs
View Form 483
15 May 2025
Apothecary Pharma LLC
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
28 Mar 2025
Wells Pharma of Houston LLC
Drugs
View Form 483
06 Jan 2025
Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Teresa I Navas
4
2
Justin A Boyd
4
3
Xiaohui Shen
3
1
Mary-Jeanet Mcgarry
2
2
June P Page
2
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
STAQ Pharma of Ohio, LLC		 16 May 2025 Normal Justification: Effective sample management is critical as proper sampling plans are essential to categorize and manage defect analysis.
Excerpt: The acceptance sampling inspection governed by procedure SOP-0052 does not clearly define reinspection parameters.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Sample Management is affected due to improper vial handling, affecting the quality of inspections.
Excerpt: Follow SOP2004 Visual Inspection by shaking and inverting the vials too forcibly.
View Details
Batch production and control records do not include in-process and laboratory control results for each batch of drug product produced.
Apothecary Pharma LLC		 15 May 2025 Normal Justification: Sample Management is implicated due to the need for comprehensive documentation of inspection results for decision-making.
Excerpt: You did not document complete results of 100% visual inspection...
View Details
In-process samples are not representative
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Sample Management is directly involved since it oversees the method and quality of in-process sample collection.
Excerpt: There is no assurance that the sampling approach is a statistically representative of each product and each lot.
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Wells Pharma of Houston LLC		 28 Mar 2025 Normal Justification: Sample Management is impacted by the failures in the visual inspection process, affecting defect detection.
Excerpt: Your firm's visual inspection training program governed by SOP HOU-QA-006 is deficient.
View Details

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