Aphena Pharma Solutions - Maryland, LLC
Form 483 issued December 15, 2021 · Easton, Maryland
- Inspection
- Dec 7 – Dec 15, 2021
- Investigators
- Juliana M. Badalucco· Mindy M. Chou· Roseline N. Boateng
- Observations
- 8
- Pages
- 8
- FEI number
- 1130591
In short: On December 15, 2021, FDA issued a Form 483 with 8 observations to Aphena Pharma Solutions - Maryland, LLC in Easton, Maryland (FEI 1130591) after an inspection that ran Dec 7 – Dec 15, 2021. The investigators were Juliana M. Badalucco, Mindy M. Chou and Roseline N. Boateng. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the packaging and labeling…
- 04
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Juliana M. Badalucco
1 document · 2021
Cites 211.130 (packaging and labeling operations) 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 8 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Aphena Pharma Solutions - Maryland, LLC?
Juliana M. Badalucco, Mindy M. Chou and Roseline N. Boateng are named on this Form 483, for the inspection of Dec 7 – Dec 15, 2021. Each investigator has a profile showing what they cite most.
When was Aphena Pharma Solutions - Maryland, LLC inspected by FDA?
The inspection ran Dec 7 – Dec 15, 2021, and the Form 483 is dated December 15, 2021.
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.