Monthly FDA ReviewsUncategorized

September 2026 FDA Warning Letter Review

FDA Inspections Team

September 2026 Warning Letter review: the selected letters below address sterile manufacturing controls, laboratory and stability practices, and biological-product requirements. This review uses the date on each letter; it is not a count of everything FDA issued or posted during the month.

Bausch & Lomb: contamination control beyond a release test

In its September 4 letter to Bausch & Lomb Inc., FDA described deficiencies involving environmental and personnel monitoring, aseptic operations, airflow protection, and investigations of microbiological departures. The letter concerned an inspection conducted in March, not September.

FDA requested broader assessments and remediation evidence. An editorial lesson for sterile manufacturers is to review the operating process and contamination-control system together, rather than relying on a passing finished-product test as the complete sterility-assurance argument.

kdc/one Chatsworth: specifications, stability, and product impact

The September 8 letter to kdc/one Chatsworth, Inc. discussed release and stability specifications, assessment of potentially affected U.S. products following a contamination event in another market, and investigations of stability failures. FDA also questioned the evidence for qualification of a third-party laboratory.

Several product details are redacted in the public letter. This article does not guess the ingredients or contaminant. The practical review question is whether an investigation explains product impact, the scope of potentially affected batches, laboratory capability, and the evidence behind the proposed actions.

NexCell Scientific: product status and manufacturing controls

In its September 11 letter to NexCell Scientific Inc., FDA stated that the umbilical cord blood-derived product described in the letter did not qualify for regulation solely under section 361 of the Public Health Service Act and lacked an approved biologics license application. The letter also described process-validation, aseptic-control, laboratory, investigation, and independent quality-unit concerns.

For firms developing human cell or tissue products, this illustrates why manufacturing readiness and the product’s regulatory pathway need separate, documented review. A quality-system project does not itself establish that a product may lawfully be marketed.

What to bring to an internal remediation review

The following are planning prompts, not additional allegations about the named firms:

  • Scope: identify the systems, products, batches, and time period being evaluated.
  • Evidence: connect each claimed correction to an approved record or attachment.
  • Owners: assign responsibility for open actions and interim controls.
  • Effectiveness: define how the team will evaluate whether the correction works.
  • Status: read the original letter and any later FDA response or closeout material before describing a firm’s current position.

A Warning Letter is distinct from a Form 483, and these letters refer to earlier inspections. They should not be combined into an invented September inspection total. For help planning an evidence-based response, see Warning Letter remediation support.

Related September reviews

Sources reviewed October 20, 2026. This is independent editorial analysis of selected public records, not an FDA publication, a complete activity count, or a determination of any firm’s current compliance.