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Sub System /
Waste Management
Waste Management
View Detailed Analysis

Analytics Overview

6
Form 483s Issued
0
483s converted to WL
6
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
02 Feb 2026
B Positive National Blood Services
Drugs
View Form 483
19 Sep 2025
A. Nelson & Co., Ltd.
Drugs
View Form 483
04 Jul 2025
Alvotech HF
Drugs
View Form 483
27 May 2025
Samsung Biologics Co., Ltd.
Drugs
View Form 483
27 May 2025
Samsung Biologics Co., Ltd.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Ze Peng
3
0
Travis S. Bradley
3
0
Haarin Chun
3
0
Peng Zhou
3
0
Arsen Karapetyan
2
0

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Records are not made concurrently with the performance of each step in the distribution of products
B Positive National Blood Services		 02 Feb 2026 Normal Justification: Proper waste management is compromised as the lack of records for biohazard waste pick-up indicates a gap in documentation and traceability.
Excerpt: Specifically, on 1/30/2026, during a review of your firm's biohazard waste management program, I observed there were no biohazard pick-up records retained.
View Details
Your firm failed to establish adequate written procedures for production and process controls
A. Nelson & Co., Ltd.		 19 Sep 2025 Normal Justification: Observation of unsecured waste indicates Waste Management process deficiencies.
Excerpt: Finished product in unsecured waste bins.
View Details
Materials management is deficient
Alvotech HF		 04 Jul 2025 Normal Justification: Lack of disposal documentation highlights deficiencies in 'Waste Management', risking regulatory non-compliance.
Excerpt: No supporting documentation could be located to verify the final disposal of this material.
View Details
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release and (b) (4) testing are deficient.
Samsung Biologics Co., Ltd.		 27 May 2025 Normal Justification: Improper waste handling and incorrect labeling found in the QC laboratory point to deficiencies in Waste Management processes.
Excerpt: The (b) (4) for QC lab waste disposal were labelled inconsistently.
View Details
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release and (b) (4) testing are deficient.
Samsung Biologics Co., Ltd.		 27 May 2025 Normal Justification: Waste Management processes include proper waste labeling and disposal protocols.
Excerpt: QC lab waste was not disposed appropriately; labels were inconsistent.
View Details

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Uncover Trends: FDA Investigator profiles & Observations.
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Waste Management

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

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Waste Management

Overview

6
Form 483s Issued
0
483s converted to WL
6
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
02 Feb 2026
B Positive National Blood Services
Drugs
View Form 483
19 Sep 2025
A. Nelson & Co., Ltd.
Drugs
View Form 483
04 Jul 2025
Alvotech HF
Drugs
View Form 483
27 May 2025
Samsung Biologics Co., Ltd.
Drugs
View Form 483
27 May 2025
Samsung Biologics Co., Ltd.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
Ze Peng
3
0
Travis S. Bradley
3
0
Haarin Chun
3
0
Peng Zhou
3
0
Arsen Karapetyan
2
0

Key Observations

TITLE/ COMPANY Issue Date Status Details
Records are not made concurrently with the performance of each step in the distribution of products
B Positive National Blood Services		 02 Feb 2026 Normal Justification: Proper waste management is compromised as the lack of records for biohazard waste pick-up indicates a gap in documentation and traceability.
Excerpt: Specifically, on 1/30/2026, during a review of your firm's biohazard waste management program, I observed there were no biohazard pick-up records retained.
View Details
Your firm failed to establish adequate written procedures for production and process controls
A. Nelson & Co., Ltd.		 19 Sep 2025 Normal Justification: Observation of unsecured waste indicates Waste Management process deficiencies.
Excerpt: Finished product in unsecured waste bins.
View Details
Materials management is deficient
Alvotech HF		 04 Jul 2025 Normal Justification: Lack of disposal documentation highlights deficiencies in 'Waste Management', risking regulatory non-compliance.
Excerpt: No supporting documentation could be located to verify the final disposal of this material.
View Details
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release and (b) (4) testing are deficient.
Samsung Biologics Co., Ltd.		 27 May 2025 Normal Justification: Improper waste handling and incorrect labeling found in the QC laboratory point to deficiencies in Waste Management processes.
Excerpt: The (b) (4) for QC lab waste disposal were labelled inconsistently.
View Details
Procedures and controls utilized within the Quality Control (QC) Laboratory in support of drug substance release and (b) (4) testing are deficient.
Samsung Biologics Co., Ltd.		 27 May 2025 Normal Justification: Waste Management processes include proper waste labeling and disposal protocols.
Excerpt: QC lab waste was not disposed appropriately; labels were inconsistent.
View Details

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