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Sub System /
Process Control
Process Control
View Detailed Analysis

Analytics Overview

93
Form 483s Issued
15
483s converted to WL
127
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
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
15
1
Pratik S Upadhyay
8
2
Taichun Qin
8
2
Ucheabuchi C Chudi-Nwankwor
8
3
Anastasia M Shields
7
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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 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
The master production and control records are deficient in that they do not include complete manufacturing and control instructions, specifications, special notations and precautions to be followed.
BSO, LLC		 27 Jun 2025 Normal Justification: Process control failures as noted in lacking documentation and verification of equipment settings and parameters.
Excerpt: The technician did not note the duration of the alarm and when the (b) (4) returned to the set point.
View Details
Your firm failed to establish adequate written procedures for production and process controls
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: The observation identifies failures in process control affecting procedures and inspection of new defects.
Excerpt: Failed to update visual inspection procedure and challenge kit to include newly identified defects.
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

93
Form 483s Issued
15
483s converted to WL
127
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
08 Aug 2025
AnazaoHealth Corporation
Drugs
View Form 483
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
11 Jul 2025
Center for Drug Evaluation and Research
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
15
1
Pratik S Upadhyay
8
2
Taichun Qin
8
2
Ucheabuchi C Chudi-Nwankwor
8
3
Anastasia M Shields
7
1

Key Observations

TITLE/ COMPANY Issue Date Status 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 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
The master production and control records are deficient in that they do not include complete manufacturing and control instructions, specifications, special notations and precautions to be followed.
BSO, LLC		 27 Jun 2025 Normal Justification: Process control failures as noted in lacking documentation and verification of equipment settings and parameters.
Excerpt: The technician did not note the duration of the alarm and when the (b) (4) returned to the set point.
View Details
Your firm failed to establish adequate written procedures for production and process controls
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: The observation identifies failures in process control affecting procedures and inspection of new defects.
Excerpt: Failed to update visual inspection procedure and challenge kit to include newly identified defects.
View Details

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