Catalent Pharma Solutions, LLC
Form 483 issued January 30, 2026 · Saint Petersburg, Florida
- Inspection
- Jan 21 – Jan 30, 2026
- Investigators
- Damaris Y. Hernandez· Nicole E. Knowlton· Tammy T. Brown
- Observations
- 2
- Pages
- 3
- FEI number
- 1811396
In short: On January 30, 2026, FDA issued a Form 483 with 2 observations to Catalent Pharma Solutions, LLC in Saint Petersburg, Florida (FEI 1811396) after an inspection that ran Jan 21 – Jan 30, 2026. The investigators were Damaris Y. Hernandez, Nicole E. Knowlton and Tammy T. Brown. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmCatalent Pharma Solutions, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. 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 Catalent Pharma Solutions, LLC?
Damaris Y. Hernandez, Nicole E. Knowlton and Tammy T. Brown are named on this Form 483, for the inspection of Jan 21 – Jan 30, 2026. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions, LLC inspected by FDA?
The inspection ran Jan 21 – Jan 30, 2026, and the Form 483 is dated January 30, 2026.
How do I get the full Form 483 for Catalent Pharma Solutions, 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.