Warning Letter – BTS S.p.A. FreeEMG and PocketEMG

Recipient: BTS S.p.A.
Product: FreeEMG and PocketEMG
Date: 5/10/2012

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. Failure to establish and maintain adequate procedures to control all documents that are required by 21 CFR 820. All obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use, as required by 21 CFR 820.40(a). For example: (b)(4) is the software version currently used for the FreeEMG and it is maintained within a folder on your firm’s computer system. However, it was observed that the previous versions of this software were not removed from the same electronic folder, were still marked as released, were still available for use, and were not marked as obsolete. We reviewed your firm’s response and conclude that it is not adequate. In the response to the observation. your firm provided a print screen showing the change so that previous software revisions are marked as obsolete and are made inaccessible. However, evidence that your firm reviewed other files to ensure that obsolete procedures were removed was not provided. Evidence that your firm updated procedures to ensure that obsolete documents were not made available was not provided. Also, your firm did not provide evidence to indicate that a systemic corrective action was considered (e.g., implementing a correction to prevent future occurrences and/or the use of obsolete documents for other products manufactured).

FDA office: CDRH

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