FDA Form 483 Response Is Not the Finish Line: What the Bausch & Lomb Warning Letter Reveals About CAPA

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FDA enforcement update graphic with warning letter on lab desk and microscope; headline says FDA Form 483 response is not the finish line

A response to an FDA Form 483 is an important regulatory step.

But it is not necessarily the end of the process.

A recent FDA Warning Letter issued to Bausch & Lomb Inc. provides a useful example of how the agency evaluates corrective and preventive actions (CAPA)—particularly when the underlying problems involve sterile manufacturing, contamination control, facility design, and the quality system.

The warning letter followed an FDA inspection of Bausch & Lomb's Tampa, Florida facility conducted from March 12 through March 20, 2026. The facility manufactures sterile prescription and over-the-counter (OTC) drug products using aseptic processing.

FDA identified significant CGMP violations involving the facility's aseptic processing operations and broader quality system.

What Did FDA Identify?

The Warning Letter describes several areas of concern, including:

Inadequate environmental and personnel monitoring
Repeated microbiological contamination in ISO 5 areas
Inadequate investigation of microbiological excursions and adverse trends
Deficiencies in aseptic processing practices and cleanroom behavior
Inadequate evaluation of unidirectional airflow
Deficiencies in dynamic smoke studies
Problems with process simulation and media fills
Inadequate contamination investigations
Insufficient management and quality unit oversight
Deficiencies in the overall pharmaceutical quality system

One particularly significant issue involved repeated recovery of microorganisms from ISO 5 areas between 2023 and 2025.

FDA noted that microorganisms were recovered from air, surfaces, and personnel, including organisms such as Serratia marcescens and Stenotrophomonas maltophilia. FDA stated that the firm continued production without adequate CAPA measures to address the persistent microbiological contamination risk.

The Important Lesson: A CAPA Commitment Is Not the Same as CAPA Completion

Perhaps the most important part of the Warning Letter is what happened after the inspection.

Bausch & Lomb submitted a response to the Form FDA 483, including corrective actions such as procedural changes and additional disinfection requirements.

However, FDA determined that the response did not adequately address the broader issues identified during the inspection.

Most notably, FDA stated that the firm's response lacked a commitment to implement significant design remediations.

This distinction matters.

If the underlying problem is caused by facility design, equipment configuration, airflow, process design, or systemic quality oversight, updating an SOP or conducting additional employee training may not adequately address the root cause.

A CAPA response must address why the problem occurred, not simply describe what employees will do differently going forward.

Sterility Testing Alone Does Not Demonstrate Process Control

Another important point in the Warning Letter concerns sterility testing.

FDA specifically stated that although sterility testing is an important quality control test for sterile drug products, it cannot be relied upon by itself to justify batch release.

The sterility test is only one element in a broader system of facility design, process controls, environmental monitoring, aseptic practices, and other measures intended to prevent contamination.

This is an important concept for sterile manufacturers and CDMOs.

A passing final test result does not necessarily demonstrate that the manufacturing process itself is adequately controlled.

For aseptic manufacturing, prevention and control of contamination must be built into the process—not simply detected at the end.

What FDA Expected in the Response

FDA requested substantially more than a general commitment to corrective action.

Among other things, the agency requested:

An independent and comprehensive review of the environmental monitoring program
A comprehensive assessment of manufacturing design and controls
Risk assessment of potential microbiological hazards
Complete investigations into potentially affected batches
Appropriate microbiological testing and specifications
A critical evaluation of airflow unidirectionality
Dynamic smoke studies after remediation
A detailed remediation plan with timelines
Assessment of aseptic practices and cleanroom behavior
Improvements to production management and quality unit oversight
Qualification and validation of extensively remediated operations

In other words, FDA is looking for evidence of systemic remediation, not simply a list of planned activities.

What This Means for OTC Drug Manufacturers

Although the facility involved in this Warning Letter manufactures sterile prescription and OTC drug products, the underlying lesson extends beyond sterile manufacturing.

For OTC manufacturers, an FDA inspection response should be evaluated from a broader perspective:

What was the observation?

What is the actual root cause?

What has been physically, procedurally, or systemically remediated?

How will the company demonstrate that the remediation is effective?

This is particularly important when an observation involves recurring deviations, inadequate investigations, facility or equipment design, quality unit oversight, or systemic CGMP weaknesses.

A response that focuses only on future training, revised SOPs, or employee reminders may not be sufficient when the underlying issue is systemic.

PCG Regulatory Insight on The Bausch & Lomb Warning Letter

The Bausch & Lomb Warning Letter illustrates an important principle in FDA inspection readiness:

A CAPA is not simply a promise to do something differently.

A meaningful CAPA should connect four elements:

1. Observation

What did FDA actually identify?

2. Root Cause

Why did the problem occur, and why was it not detected or corrected earlier?

3. Actual Remediation

What tangible changes were made to the facility, equipment, process, procedures, quality system, or management oversight?

4. Effectiveness Verification

What evidence demonstrates that the corrective action actually resolved the problem and will prevent recurrence?

This is especially important when the observation involves a systemic or design-related issue.

The key question is therefore not simply:

“Did we submit our Form 483 response?”

It is:

“Did our response demonstrate that the underlying problem has actually been understood, remediated, and placed under effective ongoing control?”

For companies preparing for an FDA inspection or responding to inspection observations, CAPA should be approached as a root-cause and remediation process—not merely a written response exercise.

Provision Consulting Group supports pharmaceutical and OTC drug manufacturers with CGMP assessments, FDA inspection readiness, Form 483 response strategy, CAPA evaluation, quality system review, and regulatory remediation planning.