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Sub System /
Process Monitoring
Process Monitoring
View Detailed Analysis

Analytics Overview

28
Form 483s Issued
2
483s converted to WL
31
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
Right Value Drug Stores LLC
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
30 Sep 2024
Pine Pharmaceuticals, LLC
Drugs
View Form 483
25 Sep 2024
Nephron Sterile Compounding Center LLC
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
3
1
Crystal Monroy
3
0
Anastasia M Shields
3
1
Edmund F Mrak
2
1
Brandy N Lepage
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status 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 observation directly highlights the absence of in-process controls, a fundamental aspect of Process Monitoring.
Excerpt: Your firm does not have validated methods or procedures for assessing the essential physical characteristics of work-in-progress (WIP) pellets.
View Details
Your firm failed to establish adequate written procedures for production and process controls
BSO, LLC		 27 Jun 2025 Normal Justification: The observation highlights a failure in monitoring and controlling the qualification process of operators, fundamental to process monitoring.
Excerpt: SOP 12 does not have defined criteria for operator re-qualification outside of retraining.
View Details
The firm lacks an adequate environmental monitoring program to ensure aseptic processing areas are maintained in a state of control.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Process monitoring involves tracking environmental conditions to ensure consistent aseptic control, which was inadequate per the observation.
Excerpt: Environmental monitoring trending reports fail to adequately assess microbiological recoveries across multiple batches.
View Details
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted
Pine Pharmaceuticals, LLC		 30 Sep 2024 Normal Justification: Inadequate defect thresholds resulted in ambiguity about which defects warrant action, negatively impacting process effectiveness.
Excerpt: Your firm's Defect limit working document lacks action levels for significant individual defects which will require investigations.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Pine Pharmaceuticals, LLC		 30 Sep 2024 Normal Justification: Process monitoring was inadequate because NVP testing was conducted only at certain times, risking contamination going undetected.
Excerpt: Your firm's non-viable particle (NVP) count monitoring is inadequate as it is not representative of the entire batch …
View Details

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Go back

Process Monitoring

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 Monitoring

Overview

28
Form 483s Issued
2
483s converted to WL
31
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
Right Value Drug Stores LLC
Drugs
View Form 483
27 Jun 2025
BSO, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
30 Sep 2024
Pine Pharmaceuticals, LLC
Drugs
View Form 483
25 Sep 2024
Nephron Sterile Compounding Center LLC
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Justin A Boyd
3
1
Crystal Monroy
3
0
Anastasia M Shields
3
1
Edmund F Mrak
2
1
Brandy N Lepage
2
0

Key Observations

TITLE/ COMPANY Issue Date Status 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 observation directly highlights the absence of in-process controls, a fundamental aspect of Process Monitoring.
Excerpt: Your firm does not have validated methods or procedures for assessing the essential physical characteristics of work-in-progress (WIP) pellets.
View Details
Your firm failed to establish adequate written procedures for production and process controls
BSO, LLC		 27 Jun 2025 Normal Justification: The observation highlights a failure in monitoring and controlling the qualification process of operators, fundamental to process monitoring.
Excerpt: SOP 12 does not have defined criteria for operator re-qualification outside of retraining.
View Details
The firm lacks an adequate environmental monitoring program to ensure aseptic processing areas are maintained in a state of control.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Process monitoring involves tracking environmental conditions to ensure consistent aseptic control, which was inadequate per the observation.
Excerpt: Environmental monitoring trending reports fail to adequately assess microbiological recoveries across multiple batches.
View Details
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted
Pine Pharmaceuticals, LLC		 30 Sep 2024 Normal Justification: Inadequate defect thresholds resulted in ambiguity about which defects warrant action, negatively impacting process effectiveness.
Excerpt: Your firm's Defect limit working document lacks action levels for significant individual defects which will require investigations.
View Details
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Pine Pharmaceuticals, LLC		 30 Sep 2024 Normal Justification: Process monitoring was inadequate because NVP testing was conducted only at certain times, risking contamination going undetected.
Excerpt: Your firm's non-viable particle (NVP) count monitoring is inadequate as it is not representative of the entire batch …
View Details

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