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Sub System /
Material Storage and Control
Material Storage and Control
View Detailed Analysis

Analytics Overview

33
Form 483s Issued
7
483s converted to WL
41
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
21 Feb 2025
Meds For Vets
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Guerlain Ulysse
5
0
Constance-Richard-Math
5
0
Logan T Williams
3
2
Arsen Karapetyan
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Procedures describing the warehousing of APIs, Intermediates and raw materials are not established.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Linked to lack of inventory systems and environmental control as described in the observation.
Excerpt: A) During the inspection, there was no complete lot tracking and inventory control systems for APIs, Intermediates and raw materials.
View Details
There is a failure to ensure that API, Intermediate, and raw materials are stored in a manner to prevent potential contamination.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: The observation highlights flawed material storage conditions that directly lead to contamination risks associated with this process type.
Excerpt: Multiple drums containing intermediates was observed to have damage to the drum walls and open lids.
View Details
Your firm released finished API's and intermediates intended for the US market to an offsite API warehouse without documentation.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The observation indicates failings in storage and documentation control linked to 'Material Storage and Control,' essential for API management.
Excerpt: It was observed that this warehouse is storing finished Active Pharmaceutical Ingredients (APIs) intended for the US market and intermediates for further processing into APIs intended for the US market without documentation or procedures.
View Details
There is a failure to establish adequate controls to prevent mix-ups during storage and distribution operations.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Mix-ups occurred due to inadequate material storage controls and lack of FIFO procedures, impacting warehouse operations.
Excerpt: There is no procedure for quarantine of incoming and outgoing products according to the Assistant Warehouse Manager and Assistant Vice President (AVP) of Warehouse.
View Details
Your facility is a warehouse that is undisclosed with the U.S FDA.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Observation highlights significant deficiencies in storage control, linked to improper label handling and lack of quality agreements.
Excerpt: There is no quality agreement between the warehouse and any of the FDA registered manufacturing facilities using this warehouse.
View Details

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Go back

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
Share

Material Storage and Control

Overview

33
Form 483s Issued
7
483s converted to WL
41
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
26 Sep 2025
Hetero Labs Limited, Unit-IX
Drugs
View Form 483
26 Sep 2025
Hetero Labs Limited (Warehouse)
Drugs
View Form 483
05 Sep 2025
Aurobindo Pharma Ltd.
Drugs
View Form 483
05 Sep 2025
Dr. Reddy's Laboratories (EU) Ltd.
Drugs
View Form 483
21 Feb 2025
Meds For Vets
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
9
0
Guerlain Ulysse
5
0
Constance-Richard-Math
5
0
Logan T Williams
3
2
Arsen Karapetyan
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Procedures describing the warehousing of APIs, Intermediates and raw materials are not established.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Linked to lack of inventory systems and environmental control as described in the observation.
Excerpt: A) During the inspection, there was no complete lot tracking and inventory control systems for APIs, Intermediates and raw materials.
View Details
There is a failure to ensure that API, Intermediate, and raw materials are stored in a manner to prevent potential contamination.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: The observation highlights flawed material storage conditions that directly lead to contamination risks associated with this process type.
Excerpt: Multiple drums containing intermediates was observed to have damage to the drum walls and open lids.
View Details
Your firm released finished API's and intermediates intended for the US market to an offsite API warehouse without documentation.
Hetero Labs Limited, Unit-IX		 26 Sep 2025 Normal Justification: The observation indicates failings in storage and documentation control linked to 'Material Storage and Control,' essential for API management.
Excerpt: It was observed that this warehouse is storing finished Active Pharmaceutical Ingredients (APIs) intended for the US market and intermediates for further processing into APIs intended for the US market without documentation or procedures.
View Details
There is a failure to establish adequate controls to prevent mix-ups during storage and distribution operations.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Mix-ups occurred due to inadequate material storage controls and lack of FIFO procedures, impacting warehouse operations.
Excerpt: There is no procedure for quarantine of incoming and outgoing products according to the Assistant Warehouse Manager and Assistant Vice President (AVP) of Warehouse.
View Details
Your facility is a warehouse that is undisclosed with the U.S FDA.
Hetero Labs Limited (Warehouse)		 26 Sep 2025 Normal Justification: Observation highlights significant deficiencies in storage control, linked to improper label handling and lack of quality agreements.
Excerpt: There is no quality agreement between the warehouse and any of the FDA registered manufacturing facilities using this warehouse.
View Details

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