KP Pharmaceutical Technology, Inc.
Form 483 issued February 3, 2023 · Bloomington, Indiana
- Inspection
- Jan 30 – Feb 3, 2023
- Investigators
- Logan T. Williams· Rafeeq Habeeb
- Observations
- 2
- Pages
- 4
- FEI number
- 3001802820
In short: On February 3, 2023, FDA issued a Form 483 with 2 observations to KP Pharmaceutical Technology, Inc. in Bloomington, Indiana (FEI 3001802820) after an inspection that ran Jan 30 – Feb 3, 2023. The investigators were Logan T. Williams and Rafeeq Habeeb. The most-cited regulation is 21 CFR 212.20 (what activities must I perform to ensure drug quality?).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not establish and follow…
- 02
You did not implement procedures and document your activities in accordance with your procedures to ensure…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmKP Pharmaceutical Technology, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KP Pharmaceutical Technology, Inc.?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 212.20 (what activities must I perform to ensure drug quality?). The opening words of each observation are shown on this page.
Who inspected KP Pharmaceutical Technology, Inc.?
Logan T. Williams and Rafeeq Habeeb are named on this Form 483, for the inspection of Jan 30 – Feb 3, 2023. Each investigator has a profile showing what they cite most.
When was KP Pharmaceutical Technology, Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 3, 2023, and the Form 483 is dated February 3, 2023.
How do I get the full Form 483 for KP Pharmaceutical Technology, Inc.?
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.