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# Exela Pharma FDA-483
- URL: https://www.fdaweb.com/exela-pharma-fda-483/
- Published: 2018-06-27T12:00:00.000Z
- Updated: 2026-09-15T00:16:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141782

FDA has released the FDA-483 issued to Exela Pharma Sciences, a Lenoir, NC, outsourcing facility, following a 9/19-9/28/17 inspection. Specific observations on the form were: 

- failing to handle and store components and drug product containers at all times in a manner to prevent contamination;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to perform routine checking of electronic equipment according to a written program designed to assure proper performance;
- failing to document in the batch production or control records results of the examination of the packaged and labeled products; and
- failing to exercise strict control over labeling issued for use in drug product labeling operations.