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# Wickliffe Pharmaceutical Has Reprocessing Issues
- URL: https://www.fdaweb.com/wickliffe-pharmaceutical-has-reprocessing-issues/
- Published: 2017-08-30T12:00:00.000Z
- Updated: 2026-09-14T22:45:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139509

FDA has released the FDA-483 issued following a 2/22-4/7/16 agency inspection at Wickliffe Pharmaceutical, a Lexington, KY, veterinary drug product producer. The [document](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm573333.pdf?ref=fdaweb.com) lists two inspection observations: 

- reprocessing procedures lack the steps to be taken to ensure that reprocessed batches will conform with all established standards, specifications, and characteristics; and
- a system by which the distribution of each lot of drug product can be readily determined to facilitate its recall, if necessary, has not been established.