INDUCTION THERAPIES LLC
Form 483 issued October 18, 2024 · Louisville, Kentucky
- Inspection
- Oct 15 – Oct 18, 2024
- Investigators
- Elizabeth R. Bloom· Geoffrey K. Kilili
- Observations
- 8
- Pages
- 7
- FEI number
- 3014171792
In short: On October 18, 2024, FDA issued a Form 483 with 8 observations to INDUCTION THERAPIES LLC in Louisville, Kentucky (FEI 3014171792) after an inspection that ran Oct 15 – Oct 18, 2024. The investigators were Elizabeth R. Bloom and Geoffrey K. Kilili. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and packaging & labeling account for 7 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks responsibility for approving or rejecting ding products manufactured, processed and packed…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to assure that corr ect labels, labeling and packaging materials are used for drug…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Elizabeth R. Bloom
2 documents · 2024–2025
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kentucky.
The firmINDUCTION THERAPIES 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 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at INDUCTION THERAPIES LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, packaging & labeling and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected INDUCTION THERAPIES LLC?
Elizabeth R. Bloom and Geoffrey K. Kilili are named on this Form 483, for the inspection of Oct 15 – Oct 18, 2024. Each investigator has a profile showing what they cite most.
When was INDUCTION THERAPIES LLC inspected by FDA?
The inspection ran Oct 15 – Oct 18, 2024, and the Form 483 is dated October 18, 2024.
How do I get the full Form 483 for INDUCTION THERAPIES 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.