Apozeal Pharmaceuticals Inc
Form 483 issued October 15, 2025 · Levittown, Pennsylvania
- Inspection
- Oct 2 – Oct 15, 2025
- Investigator
- Brandy N. Lepage
- Observations
- 5
- Pages
- 6
- FEI number
- 3004536946
In short: On October 15, 2025, FDA issued a Form 483 with 5 observations to Apozeal Pharmaceuticals Inc in Levittown, Pennsylvania (FEI 3004536946) after an inspection that ran Oct 2 – Oct 15, 2025. The investigator was Brandy N. Lepage. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 4 of 5 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 whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
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 firmApozeal Pharmaceuticals Inc history
The site's inspection history, in date order.
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 Apozeal Pharmaceuticals Inc?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Apozeal Pharmaceuticals Inc?
Brandy N. Lepage is named on this Form 483, for the inspection of Oct 2 – Oct 15, 2025. Each investigator has a profile showing what they cite most.
When was Apozeal Pharmaceuticals Inc inspected by FDA?
The inspection ran Oct 2 – Oct 15, 2025, and the Form 483 is dated October 15, 2025.
How do I get the full Form 483 for Apozeal Pharmaceuticals Inc?
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.