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Sub System /
Annual Product Quality Review
Annual Product Quality Review
View Detailed Analysis

Analytics Overview

12
Form 483s Issued
1
483s converted to WL
12
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
09 May 2025
LEESAR, INC
Drugs
View Form 483
21 Jun 2024
Brands International Corporation
Drugs
View Form 483
14 Nov 2023
Carma Laboratories, Inc.
Drugs
View Form 483
18 Oct 2023
XYZ Pharmaceuticals
Drugs
View Form 483
18 Jul 2023
ABC Pharmaceuticals Inc.
Drugs
View Form 483

Top Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
3
0
John Doe
2
0
Gavin T Cua
2
0
Jane Smith
2
0
Nibin Varghese
2
1

Observations

View all Observations
TITLE/ COMPANY Issue Date Status Details
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
LEESAR, INC		 09 May 2025 Normal Justification: The issue is directly linked to the lapses in carrying out and recording the Annual Product Quality Review, critical for maintaining drug quality.
Excerpt: your firm does not maintain written records for annual product reviews conducted for your aseptically produced drug products.
View Details
Records are not maintained so that data therein can be reviewed at least annually
Brands International Corporation		 21 Jun 2024 Normal Justification: Annual Product Quality Review is directly implicated as the observation highlights deficiencies in conducting required evaluations.
Excerpt: Your firm has failed to perform annual product review for all the OTC products manufactured at your facility.
View Details
Written procedures are not followed for evaluations conducted to review records associated with batches
Carma Laboratories, Inc.		 14 Nov 2023 Normal Justification: The deficiencies in conducting and closing APRs directly fall under Annual Product Quality Review as process type.
Excerpt: Specifically, Your firm failed to perform Annual Product Review (APR) for Domestic Lip Balm Stick and Domestic Lip Balm Tube for the year of 2022. According to your written procedure, individual APR are completed (b) (4) . Additionally, your procedure is deficient for the closure of APRs on a timely manner. For example, APR for Domestic Lip Balm Stick review period (1/1/2021 - 12/31/2021) was not completed until 12/29/2022.
View Details
Failure to ensure that all test procedures listed in the annual product review are completed
XYZ Pharmaceuticals		 18 Oct 2023 Normal Justification: The annual product review process is key for evaluating ongoing product quality; missing test data directly affects this evaluation.
Excerpt: The 2022 Annual Product Review for Product B omitted the dissolution test results for three consecutive batches.
View Details
Procedures for the annual review of records, including evaluations, are not fully implemented
ABC Pharmaceuticals Inc.		 18 Jul 2023 Normal Justification: The issue is directly linked to the annual review process, which is a critical quality management function ensuring compliance.
Excerpt: Procedures for the annual review of records, including evaluations, are not fully implemented in accordance with the written instructions.
View Details

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Annual Product Quality Review

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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Annual Product Quality Review

Overview

12
Form 483s Issued
1
483s converted to WL
12
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
09 May 2025
LEESAR, INC
Drugs
View Form 483
21 Jun 2024
Brands International Corporation
Drugs
View Form 483
14 Nov 2023
Carma Laboratories, Inc.
Drugs
View Form 483
18 Oct 2023
XYZ Pharmaceuticals
Drugs
View Form 483
18 Jul 2023
ABC Pharmaceuticals Inc.
Drugs
View Form 483

Top FDA Investigators

Investigator Name
Form 483 Count
Warning Letter Count
José E Melendez
3
0
John Doe
2
0
Gavin T Cua
2
0
Jane Smith
2
0
Nibin Varghese
2
1

Key Observations

TITLE/ COMPANY Issue Date Status Details
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
LEESAR, INC		 09 May 2025 Normal Justification: The issue is directly linked to the lapses in carrying out and recording the Annual Product Quality Review, critical for maintaining drug quality.
Excerpt: your firm does not maintain written records for annual product reviews conducted for your aseptically produced drug products.
View Details
Records are not maintained so that data therein can be reviewed at least annually
Brands International Corporation		 21 Jun 2024 Normal Justification: Annual Product Quality Review is directly implicated as the observation highlights deficiencies in conducting required evaluations.
Excerpt: Your firm has failed to perform annual product review for all the OTC products manufactured at your facility.
View Details
Written procedures are not followed for evaluations conducted to review records associated with batches
Carma Laboratories, Inc.		 14 Nov 2023 Normal Justification: The deficiencies in conducting and closing APRs directly fall under Annual Product Quality Review as process type.
Excerpt: Specifically, Your firm failed to perform Annual Product Review (APR) for Domestic Lip Balm Stick and Domestic Lip Balm Tube for the year of 2022. According to your written procedure, individual APR are completed (b) (4) . Additionally, your procedure is deficient for the closure of APRs on a timely manner. For example, APR for Domestic Lip Balm Stick review period (1/1/2021 - 12/31/2021) was not completed until 12/29/2022.
View Details
Failure to ensure that all test procedures listed in the annual product review are completed
XYZ Pharmaceuticals		 18 Oct 2023 Normal Justification: The annual product review process is key for evaluating ongoing product quality; missing test data directly affects this evaluation.
Excerpt: The 2022 Annual Product Review for Product B omitted the dissolution test results for three consecutive batches.
View Details
Procedures for the annual review of records, including evaluations, are not fully implemented
ABC Pharmaceuticals Inc.		 18 Jul 2023 Normal Justification: The issue is directly linked to the annual review process, which is a critical quality management function ensuring compliance.
Excerpt: Procedures for the annual review of records, including evaluations, are not fully implemented in accordance with the written instructions.
View Details

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