Inspections News

Inspections News

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ARTICLES

Drug

FDA Flags Vital Laboratories for Inadequate Storage, Training

The FDA cited a Vital Laboratories facility in Gujarat, India over failure to investigate out of specification results, conditions for material storage, and employee training. Read More
Drug

FDA Cites Supplement Company for Drug Claims

A Wyoming manufacturer of dietary supplements claimed drug-like qualities for its products without obtaining the drug-marketing approvals that such claims require, the FDA said in a warning letter. Read More
Device

Dialysis Solutions Company Sold Faulty Products, FDA Says

A company that manufactures and repackages solutions used in kidney dialysis was cited by the FDA for selling products that failed quality tests and had not been cleared in reinspections before shipping, according to a warning letter from the agency. Read More
Device

FDA Warns Swedish Devicemaker on Complaints, Quality Audits

The FDA issued a warning letter to Euro-Diagnostica in Malmo, Sweden for its complaint and CAPA procedures as well as its quality audits, and said the company’s responses to observations from a January inspection were inadequate. Read More
Drug

FDA Officials Highlight Compliance and Warning Letter Trends

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Drug

Magellan Rx Warned for Sterile Procedure Problems

A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile processing procedures. Read More
Device

Brazil Revamps GMP Inspections to Improve Access to New Technologies

Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new medical device technologies. Read More
Device

FDA Hits French Devicemaker for Complaint Handling, Training

Medicrea Technologies drew the FDA’s attention for inadequate complaint processing, employee training and material storage. Read More
Drug

Chinese Ointment Company Falsified Lab Results, FDA Says

A Chinese maker of pain-relief balms and ointments falsified results of tests on its products and deflected FDA inspectors seeking to examine its laboratory, the FDA said in a warning letter. Read More
Drug

FDA Bugged by Conditions at Dallas Infusion Pharmacy

The FDA cited a Dallas home infusion therapy pharmacy for failure to maintain sterile conditions for drugmaking after inspectors found dead insects in a cleanroom and in refrigerators used to store ingredients and finished products. Read More