Aphena Pharma Solutions - Maryland, LLC
Form 483 issued February 20, 2026 · Easton, Maryland
- Inspection
- Feb 17 – Feb 20, 2026
- Investigators
- David A. Oluwo· Ofuje D. Daniyan
- Observations
- 3
- Pages
- 6
- FEI number
- 1130591
In short: On February 20, 2026, FDA issued a Form 483 with 3 observations to Aphena Pharma Solutions - Maryland, LLC in Easton, Maryland (FEI 1130591) after an inspection that ran Feb 17 – Feb 20, 2026. The investigators were David A. Oluwo and Ofuje D. Daniyan. Most observations concern quality system and materials.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and…
- 03
Written procedures are lacking which describe in sufficient detail the receipt, testing, approval and rejection of…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmAphena Pharma Solutions - Maryland, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aphena Pharma Solutions - Maryland, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.
Who inspected Aphena Pharma Solutions - Maryland, LLC?
David A. Oluwo and Ofuje D. Daniyan are named on this Form 483, for the inspection of Feb 17 – Feb 20, 2026. Each investigator has a profile showing what they cite most.
When was Aphena Pharma Solutions - Maryland, LLC inspected by FDA?
The inspection ran Feb 17 – Feb 20, 2026, and the Form 483 is dated February 20, 2026.
How do I get the full Form 483 for Aphena Pharma Solutions - Maryland, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.