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The FDA Watch brief · monthly · free
What FDA cited this month, and the one thing to fix.
For plant, quality and operations leaders at OTC, personal care and consumer products manufacturers. Real FDA recall and inspection data, read by a former plant manager and FDA site contact.
- 3-minute read
- Once a month
- Free, unsubscribe anytime
What’s in each issue
Data you can act on Monday morning.
- The recall causes driving OTC, personal care, food and device recalls this month
- The Form 483 citations investigators wrote most, with the CFR reference
- Water: recalls naming water-borne organisms and water-system observations
- The Operator’s read: one practical thing to do on your floor this month
From the October 2026 issue
A taste of the last brief.
21 of 57OTC and personal care recall events in 12 months were microbial
106Form 483 observations for procedures not written or not followed, 21 CFR 211.22(d)
31Form 483 water-system observations in drug plants
Source: Claraxis FDA Watch, 12 months to October 11, 2026. Read the full October brief →
Who writes it
“What set Kobe apart was technical rigor combined with sound judgment. He was the FDA point of contact for the pilot plant in Piscataway. He doesn’t stop at diagnosing a problem; he builds the system that keeps it fixed.”
Kobe Ofori-atta
- Former plant manager of a regulated pilot manufacturing center
- Primary site FDA contact; hosted FDA inspections and quality audits with zero major findings
- Led a USP purified water system modernization
- Founder, Claraxis Group, Morristown, NJ
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