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Process Validation

Process Validation

View Detailed Analysis

Analytics Overview

61
Form 483s Issued
11
483s converted to WL
79
Total Observation
Form 483s Issued
+74 from last period

Analytics Overview

Form 483 Conversion Rate by Year
483s Not Converted to WL
483s Converted to WL
242418181212660020202020202220222023202320242024
Form 483s Issued (Yearly)
24241818121266002020202020212021202220222023202320242024

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
25 Sep 2024
Nephron Sterile Compounding Center LLC
Drugs
06 Sep 2024
Annovex Pharma, Inc.
Drugs
06 Sep 2024
Granules India Limited
Drugs
06 Sep 2024
Granules India Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
2
Anastasia M Shields
10
1
Tamil Arasu
7
0
Jeffrey P Raimondi
6
0
Joseph A Piechocki
5
0
TITLE/ COMPANY Issue Date Status Details
There is a failure to ensure that manufacturing processes are maintained in a validated state.
Dr. Reddy's Laboratories Limited (Unit II)
19 Nov 2024 Normal Justification: Failure to maintain a validated process state directly relates to 'Process Validation' due to recurring OOS results.
Excerpt: no holistic review, effective measures and/or assessment performed to ensure that the process is under adequate control
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
Nephron Sterile Compounding Center LLC
25 Sep 2024 Normal Justification: Validation processes must include thorough investigation and documentation of anomalies and testing failures.
Excerpt: You will not investigate if that (b) (4) passes the (b) (4) as to why the (b) (4) failed.
View Details
The process of material from the commonly performed ... has not been adequately assessed to ensure that material obtained from this process is of suitable quality prior to further processing.
Granules India Limited
06 Sep 2024 Normal Justification: The observation highlights deficiencies in evaluating material quality during and after the manufacturing process, which is directly related to process validation.
Excerpt: There has been no documented scientific evidence that the material (b) (4) and collected meets the minimum (b) (4) in-process check of other material prior to (b) (4) including during evaluation of samples from (b) (4) the most recent process validation.
View Details
The process of material from the commonly performed (b) (4) during routine manufacturing, including used in (b) (4) ontaining drug products for the US market, has not been adequately assessed to ensure that material obtained from this process is of suitable quality prior to further processing.
Granules India Limited
06 Sep 2024 Normal Justification: Process validation ensures materials used meet quality standards, supported by regulation in procedure GGMF194.
Excerpt: There has been no documented scientific evidence that the material (b) (4) and collected meets the minimum (b) (4) in-process check.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications.
Granules India Limited
06 Sep 2024 Normal Justification: Observation mentions failure in process validation, directly linked to process validation methods.
Excerpt: Your OOS and OOT Investigations for Process Validation (PV) batch # 3rd batch of PV) are not (b) (4).
View Details

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Process Validation
Sub-Systems

Cleaning Validation
Key FDA Trends & Insights 2025

Analyzing Evolving FDA Expectations, Risk-Based Approaches, and Data Integrity Requirements in Pharma.

Written By
Vivek Gera
Reading Time
8
Minutes

Process Validation

FDA Trends Overview

61
Form 483s Issued
11
483s converted to WL
79
Total Observation
Form 483s Issued
+74 from last period

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
25 Sep 2024
Nephron Sterile Compounding Center LLC
Drugs
06 Sep 2024
Annovex Pharma, Inc.
Drugs
06 Sep 2024
Granules India Limited
Drugs
06 Sep 2024
Granules India Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
2
Anastasia M Shields
10
1
Tamil Arasu
7
0
Jeffrey P Raimondi
6
0
Joseph A Piechocki
5
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
There is a failure to ensure that manufacturing processes are maintained in a validated state.
Dr. Reddy's Laboratories Limited (Unit II)
19 Nov 2024 Normal Justification: Failure to maintain a validated process state directly relates to 'Process Validation' due to recurring OOS results.
Excerpt: no holistic review, effective measures and/or assessment performed to ensure that the process is under adequate control
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
Nephron Sterile Compounding Center LLC
25 Sep 2024 Normal Justification: Validation processes must include thorough investigation and documentation of anomalies and testing failures.
Excerpt: You will not investigate if that (b) (4) passes the (b) (4) as to why the (b) (4) failed.
View Details
The process of material from the commonly performed ... has not been adequately assessed to ensure that material obtained from this process is of suitable quality prior to further processing.
Granules India Limited
06 Sep 2024 Normal Justification: The observation highlights deficiencies in evaluating material quality during and after the manufacturing process, which is directly related to process validation.
Excerpt: There has been no documented scientific evidence that the material (b) (4) and collected meets the minimum (b) (4) in-process check of other material prior to (b) (4) including during evaluation of samples from (b) (4) the most recent process validation.
View Details
The process of material from the commonly performed (b) (4) during routine manufacturing, including used in (b) (4) ontaining drug products for the US market, has not been adequately assessed to ensure that material obtained from this process is of suitable quality prior to further processing.
Granules India Limited
06 Sep 2024 Normal Justification: Process validation ensures materials used meet quality standards, supported by regulation in procedure GGMF194.
Excerpt: There has been no documented scientific evidence that the material (b) (4) and collected meets the minimum (b) (4) in-process check.
View Details
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications.
Granules India Limited
06 Sep 2024 Normal Justification: Observation mentions failure in process validation, directly linked to process validation methods.
Excerpt: Your OOS and OOT Investigations for Process Validation (PV) batch # 3rd batch of PV) are not (b) (4).
View Details

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