Tailor Made Compounding, LLC
Form 483 issued March 14, 2022 · Nicholasville, Kentucky
- Inspection
- Feb 14 – Mar 14, 2022
- Investigators
- Lauren N. Howard· Lisa R. Hilliard· Logan T. Williams
- Observations
- 13
- Pages
- 17
- FEI number
- 3012315020
In short: On March 14, 2022, FDA issued a Form 483 with 13 observations to Tailor Made Compounding, LLC in Nicholasville, Kentucky (FEI 3012315020) after an inspection that ran Feb 14 – Mar 14, 2022. The investigators were Lauren N. Howard, Lisa R. Hilliard and Logan T. Williams. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 12 of 13 observations.
Most cited: 21 CFR 211.113 (5×) · 211.42 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around…
- 02
Personnel manually contacted the inner surface of…
- 03
Non-microbial contamination was observed…
- 04
You had inadequate HEPA filter coverage over the area to which…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tailor Made Compounding, LLC?
FDA listed 13 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Tailor Made Compounding, LLC?
Lauren N. Howard, Lisa R. Hilliard and Logan T. Williams are named on this Form 483, for the inspection of Feb 14 – Mar 14, 2022. Each investigator has a profile showing what they cite most.
When was Tailor Made Compounding, LLC inspected by FDA?
The inspection ran Feb 14 – Mar 14, 2022, and the Form 483 is dated March 14, 2022.
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.