Catalent Pharma Solutions, LLC
Form 483 issued June 14, 2018 · St Petersburg, Florida
- Inspection
- May 29 – Jun 14, 2018
- Investigators
- Christos G. Tsingelis· Jennifer Lalama
- Observations
- 4
- Pages
- 4
- FEI number
- 1811396
In short: On June 14, 2018, FDA issued a Form 483 with 4 observations to Catalent Pharma Solutions, LLC in St Petersburg, Florida (FEI 1811396) after an inspection that ran May 29 – Jun 14, 2018. The investigators were Christos G. Tsingelis and Jennifer Lalama. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of…
- 03
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Christos G. Tsingelis
2 documents · 2018
Cites 211.113(a) (control of microbiological contamination) 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 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions, LLC?
Christos G. Tsingelis and Jennifer Lalama are named on this Form 483, for the inspection of May 29 – Jun 14, 2018. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions, LLC inspected by FDA?
The inspection ran May 29 – Jun 14, 2018, and the Form 483 is dated June 14, 2018.
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.