Inspections News

Inspections News

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ARTICLES

Device

Contract Manufacturer Fails to Validate Equipment, Document Complaints

Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility. Read More
Drug

Shionogi Facility Cited for Batch Records, Cleaning

The FDA hit Japanese API and sterile drug manufacturer Shionogi with a Form 483 for deficiencies in its production batch records and cleaning procedures. Read More
Drug

FDA Warns New York Drugmaker Over Quality Unit, Data Integrity

Apothecus Pharmaceutical drew a warning letter from the FDA for quality and data integrity violations at its manufacturing facility in Hicksville, New York. Read More
Device

Contract Manufacturer Cited for Validations, Nonconforming Product

Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More
Device

Validation Woes, Inadequate Documentation Discovered at Highland Industries

Process validation activities weren’t documented and approved, the agency said. Read More
Device

Fetal Monitor Manufacturer Cited by FDA for Documentation

The company failed to document and maintain acceptance activities as part of the device history record. Read More
Drug

EU Inspectors Cite Chinese Manufacturer for Critical Deficiencies

EU investigators found serious deficiencies in aseptic manufacturing during an inspection of the NCPC Hebei Huamin facility in Shijiazhuang, Hebei province. Read More
Drug

Mylan Draws Warning Letter for GMP Violations

Mylan was hit with an FDA warning letter for serious GMP violations at an API manufacturing facility in Andhra Pradesh, India, including improper handling of raw materials. Read More
Device

Validation, Procedures to Control Product Lax at IVD Lab

The FDA concluded that the firm’s procedures didn’t control nonconforming product. Read More
Device

Arizona Devicemaker Cited for Lack of Procedures

Procedures for finished device acceptance, design control and acceptance activities for contract manufacturers were not in place, the agency said. Read More