Spectrum Chemical: FDA hits New Jersey API manufacturer with 14 deficiencies across three sites in Form 483

Spectrum Laboratory Products is the latest API manufacturer to receive an FDA Form 483 following an inspection. The 483 includes 14 deficiencies from seven inspections between February and March of this year. The 13-page document, published October 5, details how the FDA carried out four inspections at the API manufacturer between February 8 and 24, and three inspections were carried out on March 6, 15 and 24. The issues were found across three company sites in New Jersey, including Spectrum's headquarters. Spectrum did not reply immediately to an Endpoints News request for comment. All products, APIs and non-APIs were redacted in the Form 483 document. Of the 14 observations noted, six were attributed to manufacturing process deficiencies and five were related to documentation issues. The other observations noted problems in addressing customer complaints, lack of sufficient employee training and failure to investigate or resolve any "critical deviations," such as freezer temperature issues. Manufacturing issues included risks of cross-contamination of APIs and non-APIs when repackaging products as well as failures to validate cleaning processes, microbiological and analytical test methods. The FDA noted the company did not have a proper control system over its raw materials, API and non-APIs to determine their location or status in the company's warehouse. All specifications, sampling plans and test procedures were also not "scientifically sound" to ensure Spectrum's products were of good quality and purity. The agency repeatedly observed Spectrum not effectively testing the expiration date on repackaged APIs. Other issues involved documentation. Lab control records failed to note all test data conducted, batch production and control records were not dated or signed, and there were no supporting documents for investigations into APIs that were out of specification, FDA said. Finally, Spectrum did not review and approve all quality documents for products before they were distributed, the inspection report notes. Spectrum also ran into issues with the FDA earlier this year in January, recalling three lots of its API epinephrine due to customer complaints.