Catalent Pharma Solutions, LLC
Form 483 issued March 25, 2016 · Saint Petersburg, Florida
- Inspection
- Mar 25, 2016
- Investigators
- Ileana Barreto-Pettit· Jogy George· Saleem A. Akhtar
- Observations
- 14
- Pages
- 14
- FEI number
- 1811396
In short: On March 25, 2016, FDA issued a Form 483 with 14 observations to Catalent Pharma Solutions, LLC in Saint Petersburg, Florida (FEI 1811396) after an inspection that ran Mar 25, 2016. The investigators were Ileana Barreto-Pettit, Jogy George and Saleem A. Akhtar. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.160 (3×) · 211.100 (2×)
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 llllexplained discrepancy and the failure of a batch…
- 02
An NDA-Field Alert Report was not submitted within (b) (4) of receipt of information concerning significant…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions, LLC?
FDA listed 14 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions, LLC?
Ileana Barreto-Pettit, Jogy George and Saleem A. Akhtar are named on this Form 483, for the inspection of Mar 25, 2016. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions, LLC inspected by FDA?
The inspection ran Mar 25, 2016, and the Form 483 is dated March 25, 2016.
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.