Aquestive Therapeutics
Form 483 issued January 30, 2025 · Portage, Indiana
- Inspection
- Jan 27 – Jan 30, 2025
- Investigator
- Muna Algharibeh
- Observations
- 2
- Pages
- 3
- FEI number
- 3004395604
In short: On January 30, 2025, FDA issued a Form 483 with 2 observations to Aquestive Therapeutics in Portage, Indiana (FEI 3004395604) after an inspection that ran Jan 27 – Jan 30, 2025. The investigator was Muna Algharibeh. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
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
Your firm failed to have systems in place to enable compliance with the verification…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmAquestive Therapeutics 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 Aquestive Therapeutics?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Aquestive Therapeutics?
Muna Algharibeh is named on this Form 483, for the inspection of Jan 27 – Jan 30, 2025. Each investigator has a profile showing what they cite most.
When was Aquestive Therapeutics inspected by FDA?
The inspection ran Jan 27 – Jan 30, 2025, and the Form 483 is dated January 30, 2025.
How do I get the full Form 483 for Aquestive Therapeutics?
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.