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Sub System /
Process Control
Process Control
View Detailed Analysis

Analytics Overview

96
Form 483s Issued
15
483s converted to WL
130
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
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
11
1
Ucheabuchi C Chudi-Nwankwor
8
3
Pratik S Upadhyay
7
1
Anastasia M Shields
7
1
Taichun Qin
7
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Written production and process control procedures are not followed in the execution of production and process control functions
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Process Control involves monitoring and adjusting the production process, which is directly compromised when parameter changes are not documented as observed.
Excerpt: Batch record review procedures do not ensure that the process parameters established within the batch record are adequately verified.
View Details
Your firm failed to establish adequate written procedures for production and process controls
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Lack of process control over compression speed risks uniformity and quality of pellets.
Excerpt: Your firm has not established compression speed as a controlled process parameter.
View Details
Examination and testing of samples is not done to assure that in-process materials conform to specifications.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: The observation highlights a failure in process control due to inadequate monitoring of a critical process parameter.
Excerpt: The requirement is sensor that directly comes in contact with the in-process bulk in the vessel that provides accurate readings.
View Details
Written procedures are not established that describe the in-process controls and examinations
Lupin Limited		 17 Jul 2025 Normal Justification: Observation outlines issues in effective process control during critical batch release operations.
Excerpt: Inconsistent audit trail review practices observed with staff relying on printed copies rather than direct equipment access.
View Details
Written production and process control procedures are not followed
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: The observation directly pertains to the control processes within manufacturing, where adherence to procedures is critical.
Excerpt: discrepancies and failures in the manufacturing process were not reported or investigated as required by written procedures.
View Details

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Go back

Process Control

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

Process Control

Overview

96
Form 483s Issued
15
483s converted to WL
130
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
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
17 Jul 2025
Lupin Limited
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
11
1
Ucheabuchi C Chudi-Nwankwor
8
3
Pratik S Upadhyay
7
1
Anastasia M Shields
7
1
Taichun Qin
7
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Written production and process control procedures are not followed in the execution of production and process control functions
Aurobindo Pharma Ltd.		 05 Sep 2025 Normal Justification: Process Control involves monitoring and adjusting the production process, which is directly compromised when parameter changes are not documented as observed.
Excerpt: Batch record review procedures do not ensure that the process parameters established within the batch record are adequately verified.
View Details
Your firm failed to establish adequate written procedures for production and process controls
AnazaoHealth Corporation		 08 Aug 2025 Normal Justification: Lack of process control over compression speed risks uniformity and quality of pellets.
Excerpt: Your firm has not established compression speed as a controlled process parameter.
View Details
Examination and testing of samples is not done to assure that in-process materials conform to specifications.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: The observation highlights a failure in process control due to inadequate monitoring of a critical process parameter.
Excerpt: The requirement is sensor that directly comes in contact with the in-process bulk in the vessel that provides accurate readings.
View Details
Written procedures are not established that describe the in-process controls and examinations
Lupin Limited		 17 Jul 2025 Normal Justification: Observation outlines issues in effective process control during critical batch release operations.
Excerpt: Inconsistent audit trail review practices observed with staff relying on printed copies rather than direct equipment access.
View Details
Written production and process control procedures are not followed
Center for Drug Evaluation and Research		 11 Jul 2025 Normal Justification: The observation directly pertains to the control processes within manufacturing, where adherence to procedures is critical.
Excerpt: discrepancies and failures in the manufacturing process were not reported or investigated as required by written procedures.
View Details

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