483
Moehs Catalana SLMoehs Catalana SL – FDA 483, May 18, 2018
Record Details
An FDA inspection of Moehs Catalana S.L. in Rubi, Barcelona, revealed deficiencies in their quality control unit. The firm failed to properly calibrate HPLC analytical equipment to cover all testing wavelengths and lacked a formal risk assessment for swab sampling locations during cleaning validation. These issues indicate a failure to fully adhere to established responsibilities and procedures within the quality control unit.
View Company Profile
ID · 0d4b0fb2-cbfe-4df0-8756-3cc16d99cc37
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.