Inspections News

Inspections News

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ARTICLES

Device

Xodus Medical Written Up for Complaint Handling, Production Processes

The firm’s production processes were “not conducted, controlled and monitored to ensure that a device conforms to its specification,” the agency said. Read More
Device

Virginia Specification Developer Nailed for Repeat Violations

The agency previously noted Med-Tex’s procedural failures for CAPAs and purchasing controls. Read More
Drug

Swiss Regulator Writes Up Indian Firm for Multiple Violations

Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai. Read More
Drug

Massachusetts Repackager Warned for Unsupported Expiration Dates

The FDA’s Division of Pharmaceutical Quality Operations hit repackager Loxha with a warning letter for lacking stability data and other GMP failures. 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
Drug

Torrent Pharma Warned for Contaminated Water System

A contaminated water system at one of Torrent Pharmaceuticals’ U.S. manufacturing facilities — and inadequate investigations into failing microbiological results — resulted in a second FDA warning letter for the company in a single month. Read More
Device

FDA Cites California Firm for Class II Device’s Design History File

Specifically, the firm had no design inputs, outputs, verification, validation, reviews and transfer for the device. Read More
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
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