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Sub System /
Equipment Qualification
Equipment Qualification
View Detailed Analysis

Analytics Overview

65
Form 483s Issued
13
483s converted to WL
73
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
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
5
1
Demario L Walls
4
0
Arsen Karapetyan
3
0
Crystal Monroy
3
0
Stephanie M Mongeluzzi
3
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of adequate size
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: The process involves verifying equipment's capacity, relevant to equipment qualification lacking in this case.
Excerpt: The system (b)(4) equipment was not qualified to verify the equipment capacity.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: The lack of adequate IQ, OQ, PQ highlights a direct issue with the process of Equipment Qualification, as the equipment failed to meet the critical parameters needed for its intended function.
Excerpt: The IQ,OQ,PQ (Protocol: QUAL-2025-001) for Dry Cabinet Model failed to demonstrate the equipment performs as intended.
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: Equipment Qualification is affected as the equipment is not ensurably functional for removing residual solvents.
Excerpt: The (b) (4), used in production of Estradiol granulate, has not been qualified with respect to its ability to remove residual solvents.
View Details
Equipment and utensils are not maintained at appropriate intervals to prevent contamination
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: RABS and its components must be qualified to assure their suitability for maintaining sterile environments.
Excerpt: Exposed bolt threads in the Grade A LAF and gaps around RABS components indicate qualification deficiencies.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: The issue of metal particulates due to unsuitable equipment clearly ties to equipment qualification failures.
Excerpt: The risk assessment of equipment suitability across all sterile lines identified similar equipment used in Block however this equipment was not replaced.
View Details

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Go back

Equipment Qualification

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

Equipment Qualification

Overview

65
Form 483s Issued
13
483s converted to WL
73
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
13 Jun 2025
Sun Pharmaceutical Industries Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Pratik S Upadhyay
5
1
Demario L Walls
4
0
Arsen Karapetyan
3
0
Crystal Monroy
3
0
Stephanie M Mongeluzzi
3
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of adequate size
Dr. Reddy's Laboratories Limited , FTO-11		 18 Jul 2025 Normal Justification: The process involves verifying equipment's capacity, relevant to equipment qualification lacking in this case.
Excerpt: The system (b)(4) equipment was not qualified to verify the equipment capacity.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Right Value Drug Stores LLC		 18 Jul 2025 Normal Justification: The lack of adequate IQ, OQ, PQ highlights a direct issue with the process of Equipment Qualification, as the equipment failed to meet the critical parameters needed for its intended function.
Excerpt: The IQ,OQ,PQ (Protocol: QUAL-2025-001) for Dry Cabinet Model failed to demonstrate the equipment performs as intended.
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: Equipment Qualification is affected as the equipment is not ensurably functional for removing residual solvents.
Excerpt: The (b) (4), used in production of Estradiol granulate, has not been qualified with respect to its ability to remove residual solvents.
View Details
Equipment and utensils are not maintained at appropriate intervals to prevent contamination
NATCO Pharma Limited		 19 Jun 2025 Normal Justification: RABS and its components must be qualified to assure their suitability for maintaining sterile environments.
Excerpt: Exposed bolt threads in the Grade A LAF and gaps around RABS components indicate qualification deficiencies.
View Details
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design
Sun Pharmaceutical Industries Ltd.		 13 Jun 2025 Normal Justification: The issue of metal particulates due to unsuitable equipment clearly ties to equipment qualification failures.
Excerpt: The risk assessment of equipment suitability across all sterile lines identified similar equipment used in Block however this equipment was not replaced.
View Details

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