Inspections News

Inspections News

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ARTICLES

Device

Texas Devicemaker Cited for Incomplete Records

Test results were not maintained to show acceptance criteria were met. Read More
Drug

Aurobindo Plant Slammed for Multiple Violations

The FDA cited an Aurobindo facility for lax documentation and investigations of product failures. Read More
Device

Illinois Devicemakers Cited for Quality Failures

Corrective and preventive action activities were not properly documented in three CAPAs initiated since the agency’s previous inspection. Read More
Drug

FDA’s Top Ten GMP Inspection Findings for FY 2019

An FDAnews analysis of the FDA’s GMP inspection reports for fiscal 2019 shows that drugmakers continue to stumble at the same old hurdles. Read More
Drug

California Drugmaker Warned for Drug Listing Violations

The FDA issued a warning letter to NuCare Pharmaceuticals in Orange, California for failing to fix drug listing deficiencies in the agency’s database. Read More
Device

FDA Cites Minnesota Devicemaker for Design Controls

The agency also flagged problems with a circuit board revision history. Read More
Drug

FDA Cites Texas Drugmaker for Cleanroom Deficiencies

Texas drugmaker Isotherapeutics was hit with a Form 483 for multiple violations at its Angleton facility, including problems with its cleanrooms. Read More
Device

MDR Procedures, Software Validations Net German Firm 483

Software used in the production and quality system was not validated. Read More
Device

Chinese Firm Rapped for Quality Failures

The company failed to investigate a complaint about a malfunctioning device. Read More
Device

FDA Cites Ohio Devicemaker for Arrangements With CMOs

The firm lacked procedures for inspection, testing or verification of incoming finished product. Read More