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Material Receipt and Handling
Material Receipt and Handling
View Detailed Analysis

Analytics Overview

44
Form 483s Issued
9
483s converted to WL
48
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
GenoGenix, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
11 Oct 2024
Charles River Laboratories, Inc
Drugs
View Form 483
04 Oct 2024
Empower Clinic Services, LLC dba Empower
Drugs
View Form 483
View Warning Letter
26 Jul 2024
Nubratori, Inc
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christopher R Czajka
3
0
Demario L Walls
3
2
Alan M Barker
2
0
Arsen Karapetyan
2
0
Daniel J Min
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Material Receipt and Handling processes are directly linked as failures stem from inadequate testing and validation of components upon receipt.
Excerpt: Performed at least one specific identity test on each incoming component as required and you lack confirmatory testing procedures.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components, drug product containers, and closures pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Material handling includes ensuring appropriate receipt conditions. The failure to record storage conditions upon receipt directly impacts product quality and compliance.
Excerpt: Your firm failed to record storage conditions during the receipt of Active Pharmaceutical Ingredients (APIs).
View Details
Your procedures for testing and qualifying raw materials used in the manufacture of (b) (4) are deficient
Charles River Laboratories, Inc		 11 Oct 2024 Normal Justification: The lapse results from inadequate process control during receipt and initial handling, which is the responsibility of the material receipt and handling process.
Excerpt: ...lots must be withheld from use until the lot has been sampled, tested, and released for use by the quality control unit.
View Details
Use of ingredients not intended for pharmaceutical use in non-sterile drug production
Empower Clinic Services, LLC dba Empower		 04 Oct 2024 Normal Justification: Material Receipt and Handling governs the qualification and verification of incoming raw materials. The use of non-pharmaceutical grade Azelaic Acid indicates a failure in this process.
Excerpt: Specifically, you used non-pharmaceutical grade Azelaic Acid, Lot (b) (4), as an ingredient in the production of non-sterile drug products.
View Details
Establishment of the reliability of the component supplier's report of analyses is deficient
Nubratori, Inc		 26 Jul 2024 Normal Justification: Handles the procedural compliance related to the reception and testing of raw materials.
Excerpt: Your firm failed to conduct full testing as part of the Bulk Drug Substance (BDS) re-qualification of supplier qualification.
View Details

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Go back

Material Receipt and Handling

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

Material Receipt and Handling

Overview

44
Form 483s Issued
9
483s converted to WL
48
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
GenoGenix, LLC
Drugs
View Form 483
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
View Form 483
View Warning Letter
11 Oct 2024
Charles River Laboratories, Inc
Drugs
View Form 483
04 Oct 2024
Empower Clinic Services, LLC dba Empower
Drugs
View Form 483
View Warning Letter
26 Jul 2024
Nubratori, Inc
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christopher R Czajka
3
0
Demario L Walls
3
2
Alan M Barker
2
0
Arsen Karapetyan
2
0
Daniel J Min
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity
GenoGenix, LLC		 18 Jul 2025 Normal Justification: Material Receipt and Handling processes are directly linked as failures stem from inadequate testing and validation of components upon receipt.
Excerpt: Performed at least one specific identity test on each incoming component as required and you lack confirmatory testing procedures.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components, drug product containers, and closures pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
Exela Pharma Sciences LLC		 15 Nov 2024 Normal Justification: Material handling includes ensuring appropriate receipt conditions. The failure to record storage conditions upon receipt directly impacts product quality and compliance.
Excerpt: Your firm failed to record storage conditions during the receipt of Active Pharmaceutical Ingredients (APIs).
View Details
Your procedures for testing and qualifying raw materials used in the manufacture of (b) (4) are deficient
Charles River Laboratories, Inc		 11 Oct 2024 Normal Justification: The lapse results from inadequate process control during receipt and initial handling, which is the responsibility of the material receipt and handling process.
Excerpt: ...lots must be withheld from use until the lot has been sampled, tested, and released for use by the quality control unit.
View Details
Use of ingredients not intended for pharmaceutical use in non-sterile drug production
Empower Clinic Services, LLC dba Empower		 04 Oct 2024 Normal Justification: Material Receipt and Handling governs the qualification and verification of incoming raw materials. The use of non-pharmaceutical grade Azelaic Acid indicates a failure in this process.
Excerpt: Specifically, you used non-pharmaceutical grade Azelaic Acid, Lot (b) (4), as an ingredient in the production of non-sterile drug products.
View Details
Establishment of the reliability of the component supplier's report of analyses is deficient
Nubratori, Inc		 26 Jul 2024 Normal Justification: Handles the procedural compliance related to the reception and testing of raw materials.
Excerpt: Your firm failed to conduct full testing as part of the Bulk Drug Substance (BDS) re-qualification of supplier qualification.
View Details

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