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# Form 483 Cites Repeat Observation at Outsourcing Facility
- URL: https://www.fdaweb.com/form-483-cites-repeat-observation-at-outsourcing-facility/
- Published: 2018-02-05T12:00:00.000Z
- Updated: 2026-09-14T23:19:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140675

FDA has posted a Form 483 from a 1/24-completed inspection of Houston, TX-based Empower Pharmacy that cites a repeat observation from an earlier inspection — failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless of whether the batch has been distributed, or a failure to expand an investigation to assess other batches that may also be impacted. For example, the agency said a review of the outsourcing facility’s actions with an endotoxin failure that occurred last year showed that it failed to document a root cause, it did not implement any corrective actions or preventative measures to assure that future endotoxin failures will not occur. Additionally, it said the firm did not evaluate whether other associated lots were impacted. Similar issues were also cited for a potency failure.