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An Indian plant that makes a number of drugs and active pharmaceutical ingredients (API) was socked with a six-observation Form 483 noting multiple problems with validation testing for API and drug batches, as well as the validation tests themselves. Read More
Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Read More
Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject Friday. Read More
An inspection of the Dr. Reddy’s Laboratories Andra Pradesh, India, facility two weeks ago brought the company yet another Form 483, this time for a lack of valid testing, failure to investigate out of specification (OOS) batches and inadequate control in manufacturing active pharmaceutical ingredients (API). Read More
Warning letters to FDA-registered drug manufacturing sites rose in 2023 while product recalls declined, recent trends that represent a sampling of CDER’s data-laden “2023 Report on the State of Pharmaceutical Quality” released last week. Read More
It was a blast from the past for Hybrid Pharmaceuticals, when FDA investigators observed the same corrosion, dust, and poor aseptic technique noted in inspections carried out in 2016, 2019 and 2021. Read More
Understanding what documents you must provide to the FDA during an inspection — and what’s off limits to the agency — is a key to timely and effective responses, according to inspections expert David Chesney. Read More
A Chinese drugmaker was storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, FDA investigators found during a 483 inspection. Read More