FDA 483 - Spectrum Laboratory Products, Inc. - July 14, 2021

Spectrum Laboratories Inc, a chemical manufacturing corporation in New Brunswick, NJ, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in laboratory controls, including failures to investigate discrepancies, conduct appropriate testing for repackaged APIs, maintain complete laboratory records, and perform stability studies for repackaged products. These issues indicate a lack of assurance regarding the quality, purity, and strength of drug API products distributed by the firm.