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FDA Warning Letter Explorer
FDA warning letter · Biologics

Barkey GmbH & Co. KG

Issued · Posted by FDA

FDA published a close-out letter on Aug 5, 2024. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your firm introduced a new version of this device, the Barkey plasmatherm V, in August 2021 without submitting a new premarket notification to FDA.

Passage 2

the Barkey plasmatherm V is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the changed device.

Passage 3

The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the changed device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3).

Passage 4

Your firm failed to conduct an adequate risk analysis as part of design validation, as required by 21 CFR 820.30(g).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 807.81(a)(3)
  • 21 CFR 807.81(b)
  • 21 CFR 820.30(g)
  • 21 CFR 820