483
Haw Par Healthcare LimitedHaw Par Healthcare Limited – FDA 483, Mar 1, 2019
Record Details
Haw Par Healthcare Limited in Singapore was inspected by the FDA from February 25 to March 1, 2019, and received 14 observations. The inspection revealed significant deficiencies in quality control, laboratory practices, data integrity, facility maintenance, and production controls, including repeat observations related to inadequate OOS investigations. These issues indicate a systemic failure to adhere to cGMP requirements for OTC drug manufacturing.
View Company Profile
ID · 3258265a-6763-438b-a9d4-ac8272b13205
Other documents for Haw Par Healthcare Limited
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.