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Sub System /
Change Control
Change Control
View Detailed Analysis

Analytics Overview

30
Form 483s Issued
4
483s converted to WL
33
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
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483
20 Sep 2024
Aarti Drugs Limited
Drugs
View Form 483
02 Aug 2024
ProRx LLC
Drugs
View Form 483
28 Jun 2024
Fagron Compounding Services, LLC dba Fagron Sterile Services
Drugs
View Form 483
21 Jun 2024
Cipla Limited
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
5
2
Anastasia M Shields
3
1
Yvins Dezan
3
0
Pratik S Upadhyay
3
1
Eileen A Liu
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: Change control process lacked a cleaning validation component for equipment changes.
Excerpt: You initiated several change controls... However, you have not performed a cleaning validation...
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: The observation relates to improper evaluation and classification in the change control process, linked to SOP deficiencies.
Excerpt: You classified the change control as "Minor" and your assessment for like-for-like showed the equipment are not the same for several parameters.
View Details
Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured...
Aarti Drugs Limited		 20 Sep 2024 Normal Justification: Observation of missing documentation and risk assessment upon changing operational procedures indicates change control inadequacy.
Excerpt: There is no documentation of a change control conducted to show adequate implementation and risk assessment of this change.
View Details
The responsibilities and procedures applicable to the quality control unit are not.
ProRx LLC		 02 Aug 2024 Normal Justification: Your firm fails to assess, document, mitigate risk for, track, and approve changes affecting drug product quality.
Excerpt: Your firm fails to assess, document, mitigate risk for, track, and approve changes that might impact drug product quality.
View Details
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
Fagron Compounding Services, LLC dba Fagron Sterile Services		 28 Jun 2024 Normal Justification: Change Control is relevant because no control measures were initiated related to adjacent construction impacting sterile manufacturing.
Excerpt: B. No risk assessment or change control has been initiated for the impact of ongoing adjacent construction on sterile manufacturing.
View Details

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Go back

Change 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

Change Control

Overview

30
Form 483s Issued
4
483s converted to WL
33
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
19 Nov 2024
Dr. Reddy's Laboratories Limited (Unit II)
Drugs
View Form 483
20 Sep 2024
Aarti Drugs Limited
Drugs
View Form 483
02 Aug 2024
ProRx LLC
Drugs
View Form 483
28 Jun 2024
Fagron Compounding Services, LLC dba Fagron Sterile Services
Drugs
View Form 483
21 Jun 2024
Cipla Limited
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
5
2
Anastasia M Shields
3
1
Yvins Dezan
3
0
Pratik S Upadhyay
3
1
Eileen A Liu
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and contamination
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: Change control process lacked a cleaning validation component for equipment changes.
Excerpt: You initiated several change controls... However, you have not performed a cleaning validation...
View Details
The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed
Dr. Reddy's Laboratories Limited (Unit II)		 19 Nov 2024 Normal Justification: The observation relates to improper evaluation and classification in the change control process, linked to SOP deficiencies.
Excerpt: You classified the change control as "Minor" and your assessment for like-for-like showed the equipment are not the same for several parameters.
View Details
Responsibilities and procedures for quality units are not in writing and/or followed to ensure the API and intermediates manufactured...
Aarti Drugs Limited		 20 Sep 2024 Normal Justification: Observation of missing documentation and risk assessment upon changing operational procedures indicates change control inadequacy.
Excerpt: There is no documentation of a change control conducted to show adequate implementation and risk assessment of this change.
View Details
The responsibilities and procedures applicable to the quality control unit are not.
ProRx LLC		 02 Aug 2024 Normal Justification: Your firm fails to assess, document, mitigate risk for, track, and approve changes affecting drug product quality.
Excerpt: Your firm fails to assess, document, mitigate risk for, track, and approve changes that might impact drug product quality.
View Details
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
Fagron Compounding Services, LLC dba Fagron Sterile Services		 28 Jun 2024 Normal Justification: Change Control is relevant because no control measures were initiated related to adjacent construction impacting sterile manufacturing.
Excerpt: B. No risk assessment or change control has been initiated for the impact of ongoing adjacent construction on sterile manufacturing.
View Details

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