13

Jun

2001

LLC Schering-Plough Prodcuts

0

483
Company: Schering-Plough Prodcuts, LLC
City and Sate: Manati, Puerto Rico 00674-0486
FDA District: San Juan, Puerto Rico
Dates of Inspection: 5/1/01-6/13/01

You failed to have adequate security controls for your HPLC system, once accessed by one employee is left opened and available for other personnel to gain access to the original employee’s analytical test reports. Analytical data generated by one employee can be reprocessed by another employee without the knowledge or consent of the original employee. For example, the analytical data generated for Celestone Soluspan Suspension, lots # 0-AHU-55 and 0-AHU-56 by one employee was invalidated and reprocessed by a second employee. The original employee denied knowledge of the reprocessing of the data. The computer record listed the original employee as sole owner of the record and did not indicate that any other individual entered or changed the record. There is no record to determine the identity of the individual who reprocessed the data.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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