Wickliffe Pharmaceutical, Inc.
Form 483 issued April 7, 2016 · Lexin g to n, Kentucky
- Inspection
- Feb 22 – Apr 7, 2016
- Investigator
- Michael P. Sheehan
- Observations
- 2
- Pages
- 2
- FEI number
- 3002992930
In short: On April 7, 2016, FDA issued a Form 483 with 2 observations to Wickliffe Pharmaceutical, Inc. in Lexin g to n, Kentucky (FEI 3002992930) after an inspection that ran Feb 22 – Apr 7, 2016. The investigator was Michael P. Sheehan. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.115 (reprocessing).
At a glance
Production and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.115(a) (1×) · 211.150(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with…
- 02
EMPLOYEE($) SIGNATURE A system by which the distribution of each lot of drug product can be…
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 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 211.115(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wickliffe Pharmaceutical, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and materials. The most-cited regulation is 21 CFR 211.115 (reprocessing). The opening words of each observation are shown on this page.
Who inspected Wickliffe Pharmaceutical, Inc.?
Michael P. Sheehan is named on this Form 483, for the inspection of Feb 22 – Apr 7, 2016. Each investigator has a profile showing what they cite most.
When was Wickliffe Pharmaceutical, Inc. inspected by FDA?
The inspection ran Feb 22 – Apr 7, 2016, and the Form 483 is dated April 7, 2016.
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.