California Facility Receives FDA Warning Letter

June 20, 2019
Pharmaceutical Technology Editors

FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.

FDA sent a warning letter, dated June 4, 2019, to Spectrum Laboratory Products, Inc. after an inspection of the company’s Gardena, CA facility found violations of current good manufacturing practices (CGMP) for APIs and misbranded products. The inspection was conducted from Nov. 8–16, 2018.

During the inspection, FDA inspectors found that the company had not included all quality and regulatory information received from the API manufacturer to its customers on certificates of analysis (CoAs), including names and address of the original manufacturers of repackaged API. “Customers and regulators rely on COAs for information about the quality and source of drugs and their components. Omitting information from the COA compromises supply chain accountability and traceability and may put consumers at risk,” the agency stated in the letter.

FDA requested in the letter that the company provide a remediated program for the generation of CoAs, a retrospective review of the potential impact on drug quality, and examples of recently issued CoAs with the proper information.

According to FDA, the company’s quality unit failed to perform and document adequate investigations into root causes of deviations. Customer complaints were also not thoroughly investigated, according to the agency. The letter stated that the company must provide full reports for root cause investigations performed and a comprehensive assessment of its system for investigating deviations, atypical events, and complaints.

FDA also stated that the company had not listed some products with the agency, which is required by law, and had misbranded other products. Some API labels were misidentified, according to the agency. “Since these API labels bear only Spectrum’s name without further qualifications, the labels falsely represent that Spectrum is the sole drug manufacturer. (See 21 CFR 201.1(h)(2)). Therefore, the API are misbranded under section 502(a) of the FD&C Act because the labels are false and misleading,” the agency stated.

Source: FDA