Warning Letter – Mediagnost GmbH

Recipient: Mediagnost GmbH.
Product: Human Growth Hormone diagnostic kits
Date: 5/8/12

Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example:

a. There are no procedures that address the control of electronic records.

b. Access to two computer workstations that include in-process test data, finished device testing results, and access to the firm’s network were not adequately controlled. The workstations have no access limitation controls or locks, all employees share the same user name and password, and the computers all access the firm’s overall network and records.

We reviewed your firm’s responses and conclude that they are not adequate.

Your firm did not provide a plan or documentation for correction of this observation. Your firm stated that it will evaluate the current electronic data record system and will consider switching to a paper-based system. However, your firm has not supplied any information on its proposed corrective actions.

Issuer: Center for Devices and Radiological Health (CDRH)

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