FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - December 06, 2022
Discuss this record with AI
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.
Abryl Laboratories Private Limited, a sterile drug manufacturer in Derabassi, India, was cited for significant deficiencies in its quality system. The inspection revealed failures in establishing and following procedures to prevent microbiological contamination, inadequate production and process controls, and a lack of proper validation for manufacturing processes. Additionally, the firm was found to have deficient cleaning and disinfection systems in aseptic processing areas and inconsistent record-keeping for investigations into discrepancies.
ID · abbe70ac-4c8e-417a-87cc-ac9e994efc16