Practical notes on inspection-ready pharmacy operations
Short, useful posts on pharmacy operations, inspection readiness, and evidence — from the team building Pomio.
- LatestNovember 10, 20267 min read
FDA Enforcement Part 5: What Followed a Form 483
On FDA's public compounding listing, a Form 483 from 2019 through 2023 was followed more often by a letter to the state board than by a Warning Letter, and the next step took most of a year.
Pomio teamRead post - October 27, 20265 min read
FDA Enforcement Part 4: What FDA Evaluates After Your Form 483 Response
FDA's own procedures list what it weighs after a Form 483 response, and most of the list is about evidence, scope, and whether the fix will last.
Pomio teamRead post - October 9, 20266 min read
FDA Enforcement Part 3: What Happens When FDA Comes Back
When FDA inspects a compounding pharmacy a second time, the themes it cited the first time are about twice as likely to be cited again.
Pomio teamRead post - September 27, 20269 min read
FDA Enforcement Part 2: The Failure Themes That Recur Across 439 Inspection Documents
Across 439 FDA compounding enforcement documents, sterile-environment problems show up together, and recent documents flag quality-unit, batch-record, and complaint problems far more often.
Pomio teamRead post - September 15, 20261 min read
Blog Series: FDA Enforcement
A 5-part series based on a deep dive into FDA enforcement data and what actually goes wrong in pharmacy inspections.
Pomio teamRead post - September 15, 20266 min read
FDA Enforcement Part 1: What Michigan Medicine Built After an FDA Warning Letter
What a 2017 FDA warning letter reveals about the gap between doing compliance work and being able to prove it, and what Michigan Medicine built afterward.
Pomio teamRead post - June 6, 20264 min read
The Hidden Compliance Opportunity
Compliance is moving from static documentation to operational software.
Pomio teamRead post - June 5, 20261 min read
Welcome to the Pomio blog
What this blog covers and how Pomio thinks about inspection-ready pharmacy operations.
Pomio teamRead post