Inspections News

Device

Full Range Rehab Hit for Repeat Observations

Cincinnati, Ohio-based Full Range Rehab failed to file Medical Device Reports within 30 days of receiving information that one of its devices may have caused or contributed to a serious injury, according to a 483 issued to the firm following a Jan. 30-31 inspection. Read More
Device

Valtronic Falls Short on CAPAs and Nonconforming Products

Contract device manufacturer Valtronic netted a Form 483 for inadequate CAPA procedures, nonconforming products and a failure to document validations at its Solon, Ohio plant. Read More
Drug

FDA Warns California Drugmaker for Sourcing from Sub-Standard CMOs

The FDA issued a warning letter to United Exchange Corp. for serious quality violations, including using products from “multiple sub-standard contract manufacturers” at its Cypress and Rialto drug manufacturing plants. Read More
Drug

FDA Warns Vipor Chemicals for Using Banned API Supplier

Vipor Chemicals drew a warning letter from the FDA for CGMP violations observed during an inspection last year at its facility in Vadodara, Gujarat — including the use of an API supplied by a manufacturer on an FDA import alert. Read More
Device

Plant Tagged for Missing Written Quality Procedures

Written procedures were found to be missing for a range of quality parameters at Wellman Advanced Materials’ Johnsonville, SC, plant during a Dec. 10-13, 2018 FDA inspection. Read More
Device

Belluscura Gets 483 for Failure to Evaluate Suppliers

The FDA hit Plano, Texas devicemaker Belluscura with a Form 483 for failing to properly document evaluations of potential suppliers to ensure that their products conformed to specified requirements. Read More
Drug

Indian Generics Maker Warned for Repeat CGMP Violations

Indian drugmaker Jubilant Generics drew an FDA warning letter over repeat quality violations and inadequate complaint investigations at a facility in the northern state of Uttarakhand. Read More
Drug

FDA Raps Lupin for Violations at Indian Facility

Mumbai-based drugmaker Lupin is in hot water with the FDA over violations at its API and finished-drug plant in Mandideep, Madhya Pradesh. Read More
Device

Datascope Tagged for Validation Problems

Failure to establish validation procedures or to conduct risk analysis for its Cardiosave hybrid intra-aortic balloon pumps landed Datascope a nine-item Form 483 following a July 30 to Oct. 3, 2018 FDA inspection of its Maywah, New Jersey facility. Read More
Device

Nurses Assist Gets 483 for CAPA Failures

Failure to identify actions needed to correct and prevent microbial contamination landed Nurses Assist an FDA Form 483 following an Oct. 15 to Oct. 25, 2018 inspection of the firm’s Haltom City, Texas facility. Read More