Monthly FDA ReviewsUncategorized

September 2026 FDA Roundup: 483s, Letters and Recalls

FDA Inspections Team

September 2026 FDA roundup: the companion reviews below examine selected public inspection observations, September-dated Warning Letters, and FDA-posted food recall notices. They are separate evidence streams, not interchangeable measures of enforcement activity.

Form 483s: read the observation and the date

Our Form 483 review examines September-issued records for Right Value Drug Stores and RC Outsourcing. Their public-release dates differ, including an October release for RC Outsourcing. The documents provide concrete inspection-readiness questions around aseptic evidence, investigations, and quality follow-through; they do not establish an FDA-wide trend.

Warning Letters: distinguish the letter from the earlier inspection

The Warning Letter review discusses September-dated letters to Bausch & Lomb, kdc/one Chatsworth, and NexCell Scientific. The topics include manufacturing controls, laboratory evidence, and product regulatory status. A letter’s date does not mean the underlying inspection occurred that month, and the letter alone does not establish current remediation status.

Recalls: communicate an actionable product scope

The recall review covers selected food notices involving Graziers raw milk cheeses, Lior cinnamon, Deano’s ravioli, and Mezzetta peperoncini. Each example has its own affected-product scope. They should not be converted into a count of all FDA recalls or merged with generic safety alerts.

A practical agenda for your quality meeting

  • Choose the source relevant to your operation and read the original record.
  • Identify one internal process to review; avoid assuming another firm’s finding applies automatically.
  • Ask which records demonstrate implementation, product impact, and follow-through.
  • Assign an owner and review date for any gap your own assessment identifies.

The source documents are linked and explained in each companion review. For a reusable meeting aid, explore the free member templates. For a scoped assessment, see inspection consulting services.

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.