An annual report from the FDA’s Center for Drug Evaluation and Research (CDER) says the agency’s drug manufacturing inspection activities fell short of CDER’s self-determined goals in fiscal year 2021, primarily due to COVID-related restrictions. Read More

The FDA hit Eywa Pharma’s Cranbury, N.J., drug manufacturing facility with a three-observation Form 483, citing inadequate investigations of deviations and other quality lapses. Read More

The FDA issued skincare drug product developer Clinical Formula a five-observation Form 483 for lacking an effective quality control unit and other serious deficiencies observed during a November-December 2021 inspection of its Newport Beach, Calif., facility. Read More

The FDA hit Carlsbad, Calif.-based SAFC Carlsbad — a MilliporeSigma property — with a seven-observation Form 483 following a December 2021 inspection, citing inadequate handling of biohazardous materials and other quality lapses. Read More

The FDA issued a warning letter to a contract testing laboratory at Miami University in Oxford, Ohio, for significant deviations from current good manufacturing practice (cGMP), including falsified data. Read More

Mumbai, India-based generic drugmaker Lupin has received another Form 483 inspection report from the FDA. Read More

The FDA has issued a Form 483 to a drug manufacturer and repackager in Saint Paul, Minn., for multiple deficiencies observed during a Nov. 1-18, 2021 inspection of its facility, including several that were observed during previous inspections. Read More

Belcher Pharmaceuticals received a Form 483 from the FDA for several deficiencies observed during a Nov. 1- 15, 2021, inspection of its drug manufacturing facility in Largo, Fla. Read More

Baxter Pharmaceuticals Solutions’ contract manufacturing facility in Bloomington, Ind., has received a Form 483 for several deficiencies observed during an FDA inspection from Nov. 2 through Nov. 10, 2021. Read More

Drug compounding pharmacy Ideal Specialty Apothecary of Parsippany, N.J., has received a Form 483 detailing quality deficiencies observed during an FDA inspection from Sept. 13 through Nov. 18, 2021. Read More

The FDA has issued a Form 483 to Advanced Accelerator Applications, citing quality and laboratory control issues observed during an inspection of the company’s sterile drug manufacturing facility in Millburn, N.J. Read More

Agropharma Laboratories of Salinas, Puerto Rico, has received a three-observation Form 483 citing issues with laboratory controls, cleanliness of the facility and quality control. Read More