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Material Storage and Control
Material Storage and Control
View Detailed Analysis

Analytics Overview

27
Form 483s Issued
7
483s converted to WL
29
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
121299663300201920192021202120222022202320232024202420252025
Form 483s Issued (Yearly)
12129966330020192019202020202021202120222022202320232024202420252025

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
21 Feb 2025
Meds For Vets
Drugs
16 Jan 2025
Sanofi-Aventis Deutschland GmbH
Drugs
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
06 Sep 2024
Annovex Pharma, Inc.
Drugs
27 Mar 2024
Alkem Laboratories Limited
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Lauren R Brady
2
2
Logan Williams
2
2
Joan Cantellops
2
2
Jocelyn C Turner
2
2
Margaret M Annes
2
2
TITLE/ COMPANY Issue Date Status Details
Use of ingredients not intended for pharmaceutical use in sterile drug production
Meds For Vets
21 Feb 2025 Normal Justification: The observation highlights the use of non-pharmaceutical grade materials, indicating a failure in material control processes.
Excerpt: The (b) (4) for irrigation used is labeled "not for injection".
View Details
01 not are used for storage, and of all during DS manufacturing
Sanofi-Aventis Deutschland GmbH
16 Jan 2025 Normal Justification: The observation highlights inadequate storage affecting product quality, emphasizing the need for stringent material control during storage.
Excerpt: storage, and of all during DS manufacturing process. Although Step utilizes a less stringent generation process.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers, and closures before disposition.
Exela Pharma Sciences LLC
15 Nov 2024 Normal Justification: Proper material storage controls prevent contamination risks and ensure compliance with storage conditions for rejected materials.
Excerpt: A red reject rectangular box labeled Sodium Chloride 0.9% was directly dripping (leaking) on a pallet with a Finished Product Inventory Log sheet placed on top.
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 storage directly impacts product stability. Failure to ensure proper refrigeration conditions risks quality deterioration.
Excerpt: Manufacturer’s label on raw material indicates raw material API should be kept refrigerated at (b) (4).
View Details
Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures
Annovex Pharma, Inc.
06 Sep 2024 Normal Justification: Storage requirements are critical for material integrity. The observation indicates lapses in precisely documented procedures which are vital for 'Material Storage and Control'.
Excerpt: Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures.
View Details

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Material Storage and Control

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

Material Storage and Control

Overview

27
Form 483s Issued
7
483s converted to WL
29
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
21 Feb 2025
Meds For Vets
Drugs
16 Jan 2025
Sanofi-Aventis Deutschland GmbH
Drugs
15 Nov 2024
Exela Pharma Sciences LLC
Drugs
06 Sep 2024
Annovex Pharma, Inc.
Drugs
27 Mar 2024
Alkem Laboratories Limited
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Lauren R Brady
2
2
Logan Williams
2
2
Joan Cantellops
2
2
Jocelyn C Turner
2
2
Margaret M Annes
2
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
Use of ingredients not intended for pharmaceutical use in sterile drug production
Meds For Vets
21 Feb 2025 Normal Justification: The observation highlights the use of non-pharmaceutical grade materials, indicating a failure in material control processes.
Excerpt: The (b) (4) for irrigation used is labeled "not for injection".
View Details
01 not are used for storage, and of all during DS manufacturing
Sanofi-Aventis Deutschland GmbH
16 Jan 2025 Normal Justification: The observation highlights inadequate storage affecting product quality, emphasizing the need for stringent material control during storage.
Excerpt: storage, and of all during DS manufacturing process. Although Step utilizes a less stringent generation process.
View Details
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers, and closures before disposition.
Exela Pharma Sciences LLC
15 Nov 2024 Normal Justification: Proper material storage controls prevent contamination risks and ensure compliance with storage conditions for rejected materials.
Excerpt: A red reject rectangular box labeled Sodium Chloride 0.9% was directly dripping (leaking) on a pallet with a Finished Product Inventory Log sheet placed on top.
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 storage directly impacts product stability. Failure to ensure proper refrigeration conditions risks quality deterioration.
Excerpt: Manufacturer’s label on raw material indicates raw material API should be kept refrigerated at (b) (4).
View Details
Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures
Annovex Pharma, Inc.
06 Sep 2024 Normal Justification: Storage requirements are critical for material integrity. The observation indicates lapses in precisely documented procedures which are vital for 'Material Storage and Control'.
Excerpt: Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures.
View Details

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