US Repackager Spectrum gets USFDA 483 with 14 observations Read More

Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H Akbar & Barbara Wilimczyk Marci in February 2023. The inspection revealed several fundamental GMP compliance issues. Major observations included 1) Inadequate design, qualification, monitoring, cleaning and maintenance of Packing rooms to minimize cross contamination; residue streaks on walls, table surfaces; Packing rooms not cleaned for multiple days though several lots of chemicals and APIs were repackaged 2) Cleaning procedures are not validated, not evaluated to adequately remove /neutralise high potent hazardous APIs.

Other observations include 3)poor warehouse controls – no defined areas of materials of different status, no locator system 4)inadequate investigation of critical deviations, OOS (out of specifications) and impact assessment on other lots 5) lapses in method validation, method verification 6)incomplete analytical records 7) sampling plans and specifications are not scientifically sound – identification test not performed on all containers of materials; incubation for TYMC (Yeast and Mould) test not performed in incubator, but in fumehood with temperature excursions 8) stability studies are not conducted in repackaged containers 9) repeat (Over 60) temperature excursions of refrigerator and freezer not acknowledged or investigated 10) Complaint handling and investigations are not adequate – no trend analysis to identify recurring complaints, complaint investigations do not address all issues in complaints 11) Failure of Quality unit oversight – incomplete packing records, multiple procedures addressing same subject but different in content 12) Master production records and instructions are inadequate 13) Inadequate control over documents – e.g. batch records can be reprinted and used without traceability 14) no adequate number of qualified and trained personnel.

USFDA 483