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Sub System /
Laboratory Controls
Laboratory Controls
View Detailed Analysis

Analytics Overview

82
Form 483s Issued
16
483s converted to WL
107
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
18 Jul 2025
Dr. Reddy's Laboratories Limited Formulations Technical Operations, FTO-11
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
24 Jan 2025
Turbare Manufacturing
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
19
7
Anastasia M Shields
10
4
Pratik S Upadhyay
6
3
Patty P Kaewussdangkul
6
3
Arsen Karapetyan
5
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Drug product production and control records, are not reviewed and approved by the quality control unit
Dr. Reddy's Laboratories Limited Formulations Technical Operations, FTO-11		 18 Jul 2025 Normal Justification: The observation highlights issues in laboratory operations, specifically neglect in proper documentation of microbial data.
Excerpt: The supervisor failed to document the readings during the secondary verification despite LIMS having the capability.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: Laboratory Controls are directly responsible for ensuring that sampling plans are scientifically sound to validate product quality.
Excerpt: Firm lacks a scientifically sound sampling plan for the Powdered Aluminum Hydroxide testing.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Laboratory control weaknesses manifest in the method implementation and criteria adjustments without proper rigour.
Excerpt: Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform.
View Details
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards
Turbare Manufacturing		 24 Jan 2025 Normal Justification: Laboratory controls ensure data integrity, accuracy, and review compliance. Lack of second review violates these principles, impacting regulatory adherence.
Excerpt: Your firm does not require a second reviewer for environmental monitoring results unless colony forming unit (CFU) is found.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: Laboratory controls are directly involved as they encompass the procedures and validations ensuring drug compliance with identity, strength, quality, and purity standards.
Excerpt: Laboratory controls do not include the establishment... Analytical method validation studies have not included forced degradation studies for methods used for stability testing.
View Details

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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.

Written By
Vivek Gera
Reading Time
8
Minutes
Share

Laboratory Controls

Overview

82
Form 483s Issued
16
483s converted to WL
107
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
18 Jul 2025
Dr. Reddy's Laboratories Limited Formulations Technical Operations, FTO-11
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
10 Apr 2025
Aurolige Pharma LLC
Drugs
View Form 483
24 Jan 2025
Turbare Manufacturing
Drugs
View Form 483
24 Jan 2025
Zhejiang Huahai Pharmaceutical Co., Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
19
7
Anastasia M Shields
10
4
Pratik S Upadhyay
6
3
Patty P Kaewussdangkul
6
3
Arsen Karapetyan
5
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Drug product production and control records, are not reviewed and approved by the quality control unit
Dr. Reddy's Laboratories Limited Formulations Technical Operations, FTO-11		 18 Jul 2025 Normal Justification: The observation highlights issues in laboratory operations, specifically neglect in proper documentation of microbial data.
Excerpt: The supervisor failed to document the readings during the secondary verification despite LIMS having the capability.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: Laboratory Controls are directly responsible for ensuring that sampling plans are scientifically sound to validate product quality.
Excerpt: Firm lacks a scientifically sound sampling plan for the Powdered Aluminum Hydroxide testing.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Aurolige Pharma LLC		 10 Apr 2025 Normal Justification: Laboratory control weaknesses manifest in the method implementation and criteria adjustments without proper rigour.
Excerpt: Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform.
View Details
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards
Turbare Manufacturing		 24 Jan 2025 Normal Justification: Laboratory controls ensure data integrity, accuracy, and review compliance. Lack of second review violates these principles, impacting regulatory adherence.
Excerpt: Your firm does not require a second reviewer for environmental monitoring results unless colony forming unit (CFU) is found.
View Details
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures
Zhejiang Huahai Pharmaceutical Co., Ltd.		 24 Jan 2025 Normal Justification: Laboratory controls are directly involved as they encompass the procedures and validations ensuring drug compliance with identity, strength, quality, and purity standards.
Excerpt: Laboratory controls do not include the establishment... Analytical method validation studies have not included forced degradation studies for methods used for stability testing.
View Details

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