FDA Intel

Catalent Pharma Solutions, LLC

Form 483 issued July 21, 2023 · St Petersburg, Florida

Inspection
Jul 17 – Jul 21, 2023
Investigator
Moraima J. Specs
Observations
8
Pages
4
FEI number
1811396

In short: On July 21, 2023, FDA issued a Form 483 with 8 observations to Catalent Pharma Solutions, LLC in St Petersburg, Florida (FEI 1811396) after an inspection that ran Jul 17 – Jul 21, 2023. The investigator was Moraima J. Specs. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.70 (what specifications must you establish?).

At a glance

8 of 8 observations on this 483 concern dietary supplement cgmp.

Dietary supplement CGMP8

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 111.70(b)(1)

    You did not establish an identity…

  2. 02
    21 CFR 111.70(b)(2)

    You did not establish component specifications for…

  3. 03
    21 CFR 111.70(b)(3)

    You did not establish limits for contamination that may adulterate or may lead to adulteration of…

  4. 04
    21 CFR 111.70(e)

    You did not establish product specifications for the identity, purity, strength and composition of…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Moraima J. Specs

1 document · 2023

Cites 111.70(b)(1) (what specifications must you establish?) more than any other section. Most of their documents are for sites in Florida.

The firm

Catalent Pharma Solutions, LLC history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 111.70(b)(1)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Catalent Pharma Solutions, LLC?

FDA listed 8 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.70 (what specifications must you establish?). The opening words of each observation are shown on this page.

Who inspected Catalent Pharma Solutions, LLC?

Moraima J. Specs is named on this Form 483, for the inspection of Jul 17 – Jul 21, 2023. Each investigator has a profile showing what they cite most.

When was Catalent Pharma Solutions, LLC inspected by FDA?

The inspection ran Jul 17 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.

How do I get the full Form 483 for Catalent Pharma Solutions, LLC?

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