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Sub System /
Primary Packaging
Primary Packaging
View Detailed Analysis

Analytics Overview

8
Form 483s Issued
0
483s converted to WL
8
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
10 Mar 2026
Hospira, Inc.
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
27 Jan 2026
Neeyaan LLC
Drugs
26 Sep 2025
Baxter Onocology GmbH
Drugs
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christy Osgood
1
0
David Carlson
1
0
Doan Singh
1
0
Eileen A. Liu
1
0
Charlotte P. Chang
1
0
TITLE/ COMPANY Issue Date Status Details
On 04 March 2026, observed during production of lot (b)(4) at locations
Hospira, Inc.
10 Mar 2026 Normal Justification: Primary Packaging involves handling and controlling material packaging directly, where blockage signifies a clear process breakdown.
Excerpt: stoppering system was the (b) (4) partially blocked by packaging material
View Details
Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: Lack of shipment studies and drop tests demonstrates issues within the Primary Packaging process controls.
Excerpt: No shipment studies performed to ensure physical stresses do not compromise the integrity or stability of the drug.
View Details
You did not establish packaging specifications.
Neeyaan LLC
27 Jan 2026 Normal Justification: The lack of packaging specifications directly relates to the Primary Packaging process as it involves the materials used for finished products.
Excerpt: You procure the packaging for finished dietary supplements. Packaging specifications were requested, and you stated that you do not have packaging specifications.
View Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Baxter Onocology GmbH
26 Sep 2025 Normal Justification: Issues such as taped labels and uneven surfaces near open vials concern Primary Packaging faults.
Excerpt: There was taped on labels...residues along the edges...
View Details
Regulatory standards reinforced packaging uniform cluster form accountability
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The observation highlights issues within the packaging process, indicating a failure in maintaining uniform standards and accountability.
Excerpt: packaging uniform cluster form accountability rendering resilience across efficacious elements
View Details

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Primary Packaging

Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

Primary Packaging

Overview

8
Form 483s Issued
0
483s converted to WL
8
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
10 Mar 2026
Hospira, Inc.
Drugs
10 Feb 2026
Aurobindo Pharma Limited, Unit VII
Drugs
27 Jan 2026
Neeyaan LLC
Drugs
26 Sep 2025
Baxter Onocology GmbH
Drugs
03 Apr 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions
Drugs

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Christy Osgood
1
0
David Carlson
1
0
Doan Singh
1
0
Eileen A. Liu
1
0
Charlotte P. Chang
1
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
On 04 March 2026, observed during production of lot (b)(4) at locations
Hospira, Inc.
10 Mar 2026 Normal Justification: Primary Packaging involves handling and controlling material packaging directly, where blockage signifies a clear process breakdown.
Excerpt: stoppering system was the (b) (4) partially blocked by packaging material
View Details
Complaints records are deficient in that they do not include the findings of the investigation and follow-up.
Aurobindo Pharma Limited, Unit VII
10 Feb 2026 Normal Justification: Lack of shipment studies and drop tests demonstrates issues within the Primary Packaging process controls.
Excerpt: No shipment studies performed to ensure physical stresses do not compromise the integrity or stability of the drug.
View Details
You did not establish packaging specifications.
Neeyaan LLC
27 Jan 2026 Normal Justification: The lack of packaging specifications directly relates to the Primary Packaging process as it involves the materials used for finished products.
Excerpt: You procure the packaging for finished dietary supplements. Packaging specifications were requested, and you stated that you do not have packaging specifications.
View Details
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Baxter Onocology GmbH
26 Sep 2025 Normal Justification: Issues such as taped labels and uneven surfaces near open vials concern Primary Packaging faults.
Excerpt: There was taped on labels...residues along the edges...
View Details
Regulatory standards reinforced packaging uniform cluster form accountability
Hikma Pharmaceuticals USA Inc.
23 Sep 2025 Normal Justification: The observation highlights issues within the packaging process, indicating a failure in maintaining uniform standards and accountability.
Excerpt: packaging uniform cluster form accountability rendering resilience across efficacious elements
View Details

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