Motrin IB Caplet 100 / A. Laboratory / Contract Laboratory / E. On / OBSERVATION 7 Laboratory / OBSERVATION 6 Laboratory / B. Laboratory / ES Tylenol Caplet 150 / /
Event
Product Issues / Reorganization / FDA Phase / /
Facility
Reject Station / / /
IndustryTerm
bottle manufacturer / chemical contamination / distributed finished product / manufacturing drying process / drug product / finished products / contractor site / manufacturing / filler operator / manufacturing operator / chemical / procedure operator / distributed drug product / drug products / incidents involving manufacturing / manufacturing process / /
MedicalCondition
Tylenol Arthritis / COUNTRY TYPE ESTABLISHMENT INSPECTED Las Piedras / /
Organization
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBER DATE / FDA / Drug Manufacturer Your Quality Unit / Quality Unit / /
Person
Nuria Ramirez Ordoñez / Raquel Gonzalez Rivera / Jose R Lopez / / /
Position
Investigator / supervisor / Contractor / packaging area mechanic / QA technician / Quality Site Leader / Tylenol PM / bottle containing Tylenol PM / QA Manager / representative / General Manager FIRM NAME STREET ADDRESS McNeil Healthcare / Chemist / /
This document lists observations made by the FDA representative(s) during the inspection of your facility