Service · Inspection & USP water readiness

Be ready before FDA walks in.

Practical readiness support for consumer products manufacturers: the floor habits, procedures, investigations and purified water controls that investigators look at first.

Discuss readiness Read the FDA Watch report

What FDA cited in the last 12 months

107drug-plant 483 observations for procedures not written or not followed (21 CFR 211.22(d))
96for inadequate investigations of discrepancies and failures (21 CFR 211.192)
14for objectionable-microorganism controls in non-sterile drugs (21 CFR 211.113(a))
19OTC and personal care recalls for microbial contamination, the top cause

Source: FDA Data Dashboard and openFDA, 12 months to October 2, 2026, via Claraxis FDA Watch. Drug-plant figures include OTC and prescription drug inspections.

When to call

Signs readiness needs attention.

Most findings aren’t surprises to the people on the floor. They’re gaps nobody had time to close.

  • An inspection is expected, or it has been years since the last one
  • Investigations stay open for weeks, or keep landing on “operator error”
  • Procedures say one thing and the floor does another
  • Water system micro results trend up, or alert and action limits are frequently hit
  • A recent 483 response committed to fixes that haven’t taken hold
  • A new line, product or site is coming, and nobody owns readiness end to end

What Kobe does

Readiness that lives on the floor.

  1. Walk-through

    See it the way an investigator would

    A floor-level review of manufacturing, utilities, documentation and records against what FDA has been citing, with findings ranked by risk.

  2. Water

    Purified water system review

    Design, sanitization, sampling, trending and response to excursions, drawn from leading a USP water system modernization.

  3. Investigations

    Root cause and CAPA that close

    Coach the team through investigations that find the real cause, and CAPA that is checked for effectiveness.

  4. Inspection day

    Hosting and the back room

    Prepare the people who will host and support the inspection: front room, back room, document flow and how to answer questions.

Why Kobe

He has been the FDA contact.

Relevant experience

  • Primary FDA contact for a global R&D pilot manufacturing site; hosted FDA inspections and quality audits.
  • Led a USP purified water system modernization and built an operational dashboard for critical systems.
  • Equipment and utility validation, GMP and EHS work as a process engineer (2015–2019).
  • Curates FDA Watch, a live feed of FDA findings and recalls for consumer products plants.

Claraxis provides operational readiness support. It is not a law firm and does not replace your quality unit’s regulatory responsibilities or regulatory counsel.

Related

FDA WatchUSP Water Watch: recalls and 483s ReportWhat FDA cited at consumer products plants ServiceInterim plant leadership

Start with the real challenge

Is an inspection on the horizon?

Tell Kobe what’s coming and where you’re worried. He replies personally within one business day.

Book a clarity call Email Kobe