Wickliffe Pharmaceutical, Inc.
Form 483 issued September 15, 2023 · Lexington, Kentucky
- Inspection
- Sep 15, 2023
- Investigators
- Lauren N. Howard· Logan T. Williams· Stephanie M. Mongeluzzi
- Observations
- 7
- Pages
- 8
- FEI number
- 3002992930
In short: On September 15, 2023, FDA issued a Form 483 with 7 observations to Wickliffe Pharmaceutical, Inc. in Lexington, Kentucky (FEI 3002992930) after an inspection that ran Sep 15, 2023. The investigators were Lauren N. Howard, Logan T. Williams and Stephanie M. Mongeluzzi. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
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 firmWickliffe Pharmaceutical, Inc. history
All 8 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 Wickliffe Pharmaceutical, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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 Wickliffe Pharmaceutical, Inc.?
Lauren N. Howard, Logan T. Williams and Stephanie M. Mongeluzzi are named on this Form 483, for the inspection of Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Wickliffe Pharmaceutical, Inc. inspected by FDA?
The inspection ran Sep 15, 2023, and the Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Wickliffe Pharmaceutical, 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.