We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
In 2022, FDA inspections of both foreign and domestic drug manufacturing plants were still far below pre-COVID-19 pandemic levels, although the number of citations soared, a new study has found. Read More
Kilitch Healthcare India received an FDA Form 483 citing lack of sterility, incomplete laboratory records and inadequate laboratory controls, inadequate validation of aseptic processes and unclean and insanitary buildings following an eight-day October inspection of its Mumbai, Maharashtra sterile drug manufacturing facility. Read More
Dr. Reddy’s Laboratories Telangana, India, facility received yet another FDA Form 483 after an Oct. 19-27 inspection resulted in a 25-page report detailing powdery residue in multiple places on floors and equipment, pointing to a lack of cleaning and lack of equipment maintenance, among other lapses. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Many pre-approval inspections that were in limbo because of the backlog during the pandemic are now going ahead and the uptick could result in more product approvals, according to regulatory attorney Cathy Burgess, a partner in the law firm Alston & Bird. Read More
After receiving an FDA notice of insanitary conditions at the Velocity Pharma supply plant, Cardinal Health and the Harvard Drug Group are voluntarily recalling all lots of their Velocity-produced ophthalmic products. Read More
The FDA has smacked UCB Farchim for quality control lapses, among other deficiencies, following an inspection of its Bulle, Fribourg, Switzerland facility in June and July. Read More
In a new draft guidance, the FDA describes how it requests and conducts voluntary remote regulatory assessments (RRA), an evaluation the agency says it may conduct in lieu of or in support of an inspection. Read More