Aphena Pharma Solutions - Maryland, LLC
Form 483 issued May 6, 2022 · Easton, Maryland
- Inspection
- May 3 – May 6, 2022
- Investigators
- Brandy N. Lepage· Sena G. Dissmeyer
- Observations
- 3
- Pages
- 5
- FEI number
- 1130591
In short: On May 6, 2022, FDA issued a Form 483 with 3 observations to Aphena Pharma Solutions - Maryland, LLC in Easton, Maryland (FEI 1130591) after an inspection that ran May 3 – May 6, 2022. The investigators were Brandy N. Lepage and Sena G. Dissmeyer. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The master production and control records are deficient in that they do not include complete manufacturing…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.63
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 facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Aphena Pharma Solutions - Maryland, LLC?
Brandy N. Lepage and Sena G. Dissmeyer are named on this Form 483, for the inspection of May 3 – May 6, 2022. Each investigator has a profile showing what they cite most.
When was Aphena Pharma Solutions - Maryland, LLC inspected by FDA?
The inspection ran May 3 – May 6, 2022, and the Form 483 is dated May 6, 2022.
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.