FDA 483 - Laclede, Inc. - November 07, 2018

Laclede, Inc., a medical device and drug manufacturer in Rancho Dominguez, CA, was inspected and found to have significant deficiencies in both its medical device and drug manufacturing operations. The firm lacked established design controls, risk analyses, and design history files for its medical devices. For drug products, the company failed to test active ingredient identity and strength, maintain adequate computer system controls and laboratory records, and properly manage component storage conditions.