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# FDA Releases Sancilio, FL Form 483
- URL: https://www.fdaweb.com/fda-releases-sancilio-fl-form-483/
- Published: 2017-05-22T12:00:00.000Z
- Updated: 2026-09-14T22:24:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138752

FDA has released a [Form 483](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm558502.pdf?ref=fdaweb.com) after a January inspection cited significant GMP issues at Sancilio & Co.’s Riviera Beach, FL manufacturing facility. For example, FDA said laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process materials and drug products conform to standards. The agency also cited the firm’s written stability program. “Specifically, there were constant changes of the analytical test methods used in the stability program for manufactured products dm1ng the execution of stability studies without having a scientific rationale and/or appropriate justifications,” it said.