Tailor Made Compounding, LLC
Form 483 issued October 24, 2018 · Nicholasville, Kentucky
- Inspection
- Aug 20 – Oct 24, 2018
- Investigators
- Michael P. Sheehan· Nicholas L. Paulin
- Observations
- 12
- Pages
- 8
- FEI number
- 3012315020
In short: On October 24, 2018, FDA issued a Form 483 with 12 observations to Tailor Made Compounding, LLC in Nicholasville, Kentucky (FEI 3012315020) after an inspection that ran Aug 20 – Oct 24, 2018. The investigators were Michael P. Sheehan and Nicholas L. Paulin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control…
This inspection in context
Michael P. Sheehan
6 documents · 2011–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmTailor Made Compounding, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Tailor Made Compounding, LLC?
FDA listed 12 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Tailor Made Compounding, LLC?
Michael P. Sheehan and Nicholas L. Paulin are named on this Form 483, for the inspection of Aug 20 – Oct 24, 2018. Each investigator has a profile showing what they cite most.
When was Tailor Made Compounding, LLC inspected by FDA?
The inspection ran Aug 20 – Oct 24, 2018, and the Form 483 is dated October 24, 2018.
How do I get the full Form 483 for Tailor Made Compounding, 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.