Most Common FDA 483 Observations on Batch Release

Batch release is the final gate between manufacturing and market—and regulators are increasingly scrutinizing it. Incomplete, inaccurate, or uncontrolled batch release processes have led to some of the most serious FDA Form 483 citations.

This blog highlights the top FDA 483 observations related to batch release, listing the companies issued, dates of issue, and the investigators involved. Alongside, we share the corrective and preventive actions you must prioritize to stay compliant.

1. Lack of Microbial Control in Batch Release

• Company Issued: Central Admixture Pharmacy Services
• Date Issued: 2013-02-19
• Investigator: Philip Kreiter

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Observation:
There is a lack of microbial reduction or control in the batch release process for sterile products.

Corrective Action:
Establish detailed microbial control procedures integrated into batch release SOPs.

Preventive Action:
Implement continuous microbial monitoring and corrective training programs for aseptic practices.

2. Absence of Control Procedures for Critical Variables

• Company Issued: Nephron Sterile Compounding Center
• Date Issued: 2023-02-10
• Investigator: Mary-Jeanet Mcgarry

Observation:
No control procedures were established to verify critical process variables before batch release.

Corrective Action:
Develop a comprehensive facility maintenance and environmental monitoring program linked directly to batch release criteria.

Preventive Action:
Establish a routine inspection schedule to immediately identify and correct environmental or process deviations.

3. Drug Products Released Without Confirming Freedom from Contamination

• Company Issued: US Specialty Formulations
• Date Issued: 2022-04-26
• Investigator: Edmund F Mrak

Observation:
Batches were released without documented evidence that products were free from contamination.

Corrective Action:
Revise batch release procedures to require documented sterility testing before lot release.

Preventive Action:
Incorporate in-process microbial testing checkpoints during manufacturing phases.

4. Excessive Manual Interventions in Aseptic Processes

• Company Issued: Central Admixture Pharmacy Services
• Date Issued: 2013-02-19
• Investigator: Maya M Davis

Observation:
Numerous manual aseptic manipulations were performed without appropriate controls before batch release.

Corrective Action:
Redesign aseptic processes to minimize manual interventions and automate critical steps.

Preventive Action:
Enhance aseptic technique training and monitor manual interventions as part of batch release reviews.

5. No Potency Testing Conducted Before Batch Release

• Company Issued: Central Admixture Pharmacy Services
• Date Issued: 2013-02-19
• Investigator: Ramon E Martinez

Observation:
Finished drug products were released without conducting potency tests.

Corrective Action:
Update quality control procedures to mandate potency testing prior to batch release approval.

Preventive Action:
Schedule periodic potency verification checks at both in-process and final stages of production.
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✅ Download: Audit Readiness Checklist for Batch Release

We’ve created an Audit Readiness Checklist specifically designed to help pharma teams review their batch release compliance, covering:

• Verification of all critical product attributes
• Documentation of environmental and microbial controls
• Proper sign-off and QA approval processes
• Tracking of manual interventions and deviations
• Investigator-specific hot zones

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