483s Alerts

Full Issue

June 11, 2014

Dear Subscriber,

The following 483s recently have been added to 483sOnline.com. To access all available 483s, visit us at http://www.fdanews.com/form483.

Mission Pharmacal Co.
Issued: 02/07/2014 Region: Southwest Inspector(s): Lucas B. Leake; Diana L. Ayala
Observations: Written procedures are not established that describe the in-process controls and tests to be conducted on appropriate samples of in-process materials of each batch.

Advance Pharmaceuticals, Inc.
Issued: 12/19/2013 Region: Northeast Inspector(s): Robert C. Horan
Observations: The responsibilities and procedures applicable to the quality control unit are not fully followed.

Omega & Delta Co., Inc.
Issued: 12/10/2013 Region: Southeast Inspector(s): Miguel A. Martinez
Observations: The responsibilities and procedures applicable to the quality control unit are not fully followed.

11th Annual Medical Device Quality Congress: Managing the “Big Five” Quality Concerns, June 24 - 26, 2014, Bethesda, MD More than 90% of FDA device warning letters fall into 5 categories: 1) Risk management; 2) Design control; 3) Supplier quality; 4) QSR compliance and 5) Postmarket surveillance. At FDAnews, we call them the “Big Five.”  If you’re concerned about quality issues — and who isn't? — you very likely need our Big Five FixTM. Where do you get it? Sign up TODAY for the best-attended annual conference for devicemakers, now in its 11th year.

American Medical Systems, Inc.
Issued: 02/24/2014 Region: Central Inspector(s): Benjamin W. Anderson; Kyle J. Mccracken
Observations: A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.

Medtronic Navigation, Inc.
Issued: 03/05/2014 Region: Southwest Inspector(s): Ashleigh P. Barkans; Laura B. Kennedy; Amanda S. Zorn
Observation: Design validation did not ensure the device conforms to defined user needs and intended uses.

AT Squared
Issued: 02/13/2014 Region: Central Inspector(s): Brigitte K. H. Strelnik
Observations: Procedures for design validation have not been adequately established.

Preparing for an Inspection: Best Practices Gap Analysis — In this report from FDAnews, David Lim, “the Regulatory Doctor” and former CDRH officer, shows you how using data from past inspections can guide your company in developing your own inspection gap analysis. This is the perfect resource for all your employees; whether they are new to the company or long time veterans. Order today.