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Distribution

View Detailed Analysis

Analytics Overview

5
Form 483s Issued
2
483s converted to WL
6
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
2.02.01.31.30.70.70.00.020192019202220222023202320242024
Form 483s Issued (Yearly)
2.02.01.31.30.70.70.00.0201920192020202020212021202220222023202320242024

Recent Form 483s & Warning Letters

View all 483’s
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
12 Jul 2024
Lonza Netherlands B.V.
Drugs
View Form 483
08 Sep 2023
Sichuan Deebio Pharmaceutical Co. Ltd.
Drugs
View Form 483
10 Mar 2023
Hugel, Inc. (Site 2)
Drugs
View Form 483
11 Feb 2022
Family Dollar Distribution Inc.
Drugs
View Form 483
View Warning Letter
20 Mar 2019
ACRX Specialty Pharmacy Inc
Drugs
View Form 483
View Warning Letter

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
2
2
Michael L Jones
2
2
Jocelyn C Turner
2
2
Lauren R Brady
2
2
Preston B Hoover
2
2

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
The process (equipment and procedures) for the storage and shipment of commercial drug product (DP) has not been validated
Lonza Netherlands B.V.		 12 Jul 2024 Normal Justification: Distribution processes are affected as they require validated methods for shipping drug products.
Excerpt: The proposed commercial DP shipping validation study has not been performed.
View Details
Control procedures are not established which validate the performance of distribution processes
Sichuan Deebio Pharmaceutical Co. Ltd.		 08 Sep 2023 Normal Justification: Distribution is fundamentally linked to this observation as it involves the processes ensuring that the drug substance remains within specified conditions during shipping.
Excerpt: your firm ships USP drug substance with temperature storage specifications of (1) (b) (b) to (4) degrees Celsius for temperature, and (b) (4) % RH. There is no official validation study regarding the shipping container and components used which provide assurance that the (b) (4) USP drug substance in transit stays within its specified range for the duration of the shipment.
View Details
Your firm's quality unit's oversight of your GMP manufacturing operations is inadequate.
Hugel, Inc. (Site 2)		 10 Mar 2023 Normal Justification: Unvalidated shipping conditions may affect sample integrity.
Excerpt: Shipping validations for samples tested in your contractor testing laboratories have not been conducted.
View Details
Distribution records do not contain the lot or control number of drug product
Family Dollar Distribution Inc.		 11 Feb 2022 Normal Justification: The failure to record lot numbers directly impacts the Distribution process, as it is essential for tracking and tracing drug products throughout the supply chain.
Excerpt: Specifically, your firm does not document in your inventory control system the lot numbers of drug products received by your facility. In addition, your firm does not document the lot numbers of drug products that are shipped/distributed from your facility to your stores.
View Details
Drug products are not stored under appropriate conditions of temperature and humidity SO that their identity, strength, quality, and purity are not affected.
Family Dollar Distribution Inc.		 11 Feb 2022 Normal Justification: The observation indicates a failure to maintain controlled environmental conditions in the warehouse, crucial for preserving drug product quality during storage.
Excerpt: Specifically, your firm does not monitor nor control temperature or humidity within your warehouse...
View Details

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Distribution
Sub-Systems

Cleaning Validation
Key FDA Trends & Insights 2025

Analyzing Evolving FDA Expectations, Risk-Based Approaches, and Data Integrity Requirements in Pharma.

Written By
Vivek Gera
Reading Time
8
Minutes

Distribution

FDA Trends Overview

5
Form 483s Issued
2
483s converted to WL
6
Total Observation
Form 483s Issued
+74 from last period

FDA Trends

Form 483 Conversion Rate by Year
483s Not Converted to WL
483s Converted to WL
2.02.01.31.30.70.70.00.020192019202220222023202320242024
Form 483s Issued (Yearly)
2.02.01.31.30.70.70.00.0201920192020202020212021202220222023202320242024

Recent Form 483s & Warning Letters

Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
12 Jul 2024
Lonza Netherlands B.V.
Drugs
View Form 483
08 Sep 2023
Sichuan Deebio Pharmaceutical Co. Ltd.
Drugs
View Form 483
10 Mar 2023
Hugel, Inc. (Site 2)
Drugs
View Form 483
11 Feb 2022
Family Dollar Distribution Inc.
Drugs
View Form 483
View Warning Letter
20 Mar 2019
ACRX Specialty Pharmacy Inc
Drugs
View Form 483
View Warning Letter

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Margaret M Annes
2
2
Michael L Jones
2
2
Jocelyn C Turner
2
2
Lauren R Brady
2
2
Preston B Hoover
2
2

Key Observations

TITLE/ COMPANY Issue Date Status Details
The process (equipment and procedures) for the storage and shipment of commercial drug product (DP) has not been validated
Lonza Netherlands B.V.		 12 Jul 2024 Normal Justification: Distribution processes are affected as they require validated methods for shipping drug products.
Excerpt: The proposed commercial DP shipping validation study has not been performed.
View Details
Control procedures are not established which validate the performance of distribution processes
Sichuan Deebio Pharmaceutical Co. Ltd.		 08 Sep 2023 Normal Justification: Distribution is fundamentally linked to this observation as it involves the processes ensuring that the drug substance remains within specified conditions during shipping.
Excerpt: your firm ships USP drug substance with temperature storage specifications of (1) (b) (b) to (4) degrees Celsius for temperature, and (b) (4) % RH. There is no official validation study regarding the shipping container and components used which provide assurance that the (b) (4) USP drug substance in transit stays within its specified range for the duration of the shipment.
View Details
Your firm's quality unit's oversight of your GMP manufacturing operations is inadequate.
Hugel, Inc. (Site 2)		 10 Mar 2023 Normal Justification: Unvalidated shipping conditions may affect sample integrity.
Excerpt: Shipping validations for samples tested in your contractor testing laboratories have not been conducted.
View Details
Distribution records do not contain the lot or control number of drug product
Family Dollar Distribution Inc.		 11 Feb 2022 Normal Justification: The failure to record lot numbers directly impacts the Distribution process, as it is essential for tracking and tracing drug products throughout the supply chain.
Excerpt: Specifically, your firm does not document in your inventory control system the lot numbers of drug products received by your facility. In addition, your firm does not document the lot numbers of drug products that are shipped/distributed from your facility to your stores.
View Details
Drug products are not stored under appropriate conditions of temperature and humidity SO that their identity, strength, quality, and purity are not affected.
Family Dollar Distribution Inc.		 11 Feb 2022 Normal Justification: The observation indicates a failure to maintain controlled environmental conditions in the warehouse, crucial for preserving drug product quality during storage.
Excerpt: Specifically, your firm does not monitor nor control temperature or humidity within your warehouse...
View Details

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