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Sub System /
Process Validation
Process Validation
View Detailed Analysis

Analytics Overview

88
Form 483s Issued
15
483s converted to WL
112
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
7
Anastasia M Shields
10
6
Demario L Walls
5
0
Arsen Karapetyan
5
1
Joseph A Piechocki
5
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Process Validation is identified due to failure in validating aseptic processes critical for sterile production integrity.
Excerpt: Poor visualization was seen due to inadequate generation of smoke to ensure that (b) (4) sweeping unidirectional airflow is present.
View Details
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: The lack of validation studies is critical to ensuring that the manufacturing process reliably produces quality products.
Excerpt: There are no documented validation studies demonstrating that your hormonal pellet manufacturing process consistently produces pellets meeting specifications.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: OOS results were recurring, indicating poorly validated processes unable to ensure consistency.
Excerpt: OOS results... were recurring in nature due to system failures.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
BSO, LLC		 27 Jun 2025 Normal Justification: Process Validation is affected due to absence of validated equivalency between qualification and actual processing conditions.
Excerpt: No study was provided to demonstrate equivalency between the qualification materials and actual product formulation.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
BSO, LLC		 27 Jun 2025 Normal Justification: Validation is a key part of any process to ensure consistency and reliability. Failure to validate fully exposes the product to contamination risks.
Excerpt: Your firm failed to establish and document adequate validation of the (b) (4) sterilization process used for Estradiol Pellets.
View Details

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Go back

Process Validation

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 Validation

Overview

88
Form 483s Issued
15
483s converted to WL
112
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
18 Jul 2025
Dr. Reddy's Laboratories Limited , FTO-11
Drugs
View Form 483
18 Jul 2025
Right Value Drug Stores LLC
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
19 Jun 2025
NATCO Pharma Limited
Drugs
View Form 483
23 May 2025
Stokes Healthcare Inc. dba Epicur Pharma
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
14
7
Anastasia M Shields
10
6
Demario L Walls
5
0
Arsen Karapetyan
5
1
Joseph A Piechocki
5
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: Process Validation is identified due to failure in validating aseptic processes critical for sterile production integrity.
Excerpt: Poor visualization was seen due to inadequate generation of smoke to ensure that (b) (4) sweeping unidirectional airflow is present.
View Details
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: The lack of validation studies is critical to ensuring that the manufacturing process reliably produces quality products.
Excerpt: There are no documented validation studies demonstrating that your hormonal pellet manufacturing process consistently produces pellets meeting specifications.
View Details
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: OOS results were recurring, indicating poorly validated processes unable to ensure consistency.
Excerpt: OOS results... were recurring in nature due to system failures.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
BSO, LLC		 27 Jun 2025 Normal Justification: Process Validation is affected due to absence of validated equivalency between qualification and actual processing conditions.
Excerpt: No study was provided to demonstrate equivalency between the qualification materials and actual product formulation.
View Details
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
BSO, LLC		 27 Jun 2025 Normal Justification: Validation is a key part of any process to ensure consistency and reliability. Failure to validate fully exposes the product to contamination risks.
Excerpt: Your firm failed to establish and document adequate validation of the (b) (4) sterilization process used for Estradiol Pellets.
View Details

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