483
Cephas Life Sciences Private LimitedCephas Life Sciences Private Limited – FDA 483, May 18, 2023
Record Details
Cephas Life Sciences Private Limited, a chemical analytical laboratory in Taramani, Chennai, received a Form 483 with three observations. The inspection revealed deficiencies in laboratory controls, including scientifically unsound out-of-specification procedures and unsupported extraction methods. Additionally, the firm failed to justify deviations from written sampling plans and lacked a quality agreement for contract manufactured drug products.
View Company Profile
ID · 8c272a57-7bfc-4e27-ae08-99b424cf4021
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.