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Sub System /
Process Control
Process Control
View Detailed Analysis

Analytics Overview

115
Form 483s Issued
15
483s converted to WL
152
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483
05 Dec 2025
STAQ Pharma of Ohio, LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
1
David Carlson
11
0
Christy Osgood
11
0
Kiya Hamilton
11
0
LaiMing Lee
11
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Process Control is affected as the variability was not analyzed, indicating a failure in controlling essential process parameters.
Excerpt: Your Quality Unit has failed to investigate the causes of the extreme variability in filling and production time.
View Details
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Process control is compromised by undefined limits and procedures for operational variables.
Excerpt: No defined (b)(4) limit, master batch record instructions or SOPs for the (b)(4) limit and rate.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: CCTV systems serve as quality assurance tools for identifying breaches in aseptic practices; flaws directly affect process control.
Excerpt: CCTV system serves as the primary method for Quality Assurance personnel to review filling operations and identify potential breaches.
View Details
There is a lack of adequate controls in place to minimize the carryover of the residual materials
Ipca Laboratories Limited		 05 Dec 2025 Normal Justification: Process control issues arise from undefined procedure limits, leading to potential contamination risks.
Excerpt: Your control procedure TARA/PRD/088/R01 does not define the campaign length in terms of maximum number of days.
View Details
Your firm failed to establish adequate written procedures for production and process control
STAQ Pharma of Ohio, LLC		 05 Dec 2025 Normal Justification: Failure in process control procedures directly impacts consistency in drug product quality attributes.
Excerpt: Your firm failed to establish adequate written procedures for production and process control...
View Details

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Process Control

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

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Process Control

Overview

115
Form 483s Issued
15
483s converted to WL
152
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
20 Feb 2026
Maiva Pharma Private Limited
Drugs
View Form 483
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
View Form 483
06 Feb 2026
Eugia Pharma Specialities Limited
Drugs
View Form 483
05 Dec 2025
Ipca Laboratories Limited
Drugs
View Form 483
05 Dec 2025
STAQ Pharma of Ohio, LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
1
David Carlson
11
0
Christy Osgood
11
0
Kiya Hamilton
11
0
LaiMing Lee
11
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes.
Maiva Pharma Private Limited		 20 Feb 2026 Normal Justification: Process Control is affected as the variability was not analyzed, indicating a failure in controlling essential process parameters.
Excerpt: Your Quality Unit has failed to investigate the causes of the extreme variability in filling and production time.
View Details
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures.
Aurobindo Pharma Limited, Unit VII		 10 Feb 2026 Normal Justification: Process control is compromised by undefined limits and procedures for operational variables.
Excerpt: No defined (b)(4) limit, master batch record instructions or SOPs for the (b)(4) limit and rate.
View Details
The responsibilities and procedures applicable to the quality control unit are not fully followed
Eugia Pharma Specialities Limited		 06 Feb 2026 Normal Justification: CCTV systems serve as quality assurance tools for identifying breaches in aseptic practices; flaws directly affect process control.
Excerpt: CCTV system serves as the primary method for Quality Assurance personnel to review filling operations and identify potential breaches.
View Details
There is a lack of adequate controls in place to minimize the carryover of the residual materials
Ipca Laboratories Limited		 05 Dec 2025 Normal Justification: Process control issues arise from undefined procedure limits, leading to potential contamination risks.
Excerpt: Your control procedure TARA/PRD/088/R01 does not define the campaign length in terms of maximum number of days.
View Details
Your firm failed to establish adequate written procedures for production and process control
STAQ Pharma of Ohio, LLC		 05 Dec 2025 Normal Justification: Failure in process control procedures directly impacts consistency in drug product quality attributes.
Excerpt: Your firm failed to establish adequate written procedures for production and process control...
View Details

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