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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
Inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva found on employee clothing are among the litany of observations from an FDA Form 483 levied on Shanghai-based CARsgen Therapeutics. Read More
One of the biggest mistakes companies make in their responses to the FDA’s inspection observations is to focus on the specific issues raised without looking at the bigger picture, according to one regulatory compliance expert. Read More
Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to have an approved BLA. Read More