Pharma Journal

Spectrum Laboratories is the new API manufacturer hit with FDA form 483.

The form 483 has 14 deficiencies. Of the 14 observations noted, six are attributed to manufacturing process deficiencies and five are 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.

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...