BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Baylab USA, LLC

Issued · Posted by FDA

FDA published a close-out letter on Sep 14, 2026. 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

Failure to establish and maintain requirements, including quality requirements, that must be met by suppliers, contractors, and consultants as required by 21 CFR § 820.50(a).

Passage 2

Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR § 820.22.

Passage 3

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR § 820.198(a).

Passage 4

Failure to adequately develop, maintain, and implement written medical device reporting (MDR) procedures as required by 21 CFR 803.17.

Citations in the original letter

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

  • 21 CFR 801.20(a)
  • 21 CFR 801.3
  • 21 CFR 801.40(a)(1)
  • 21 CFR 801.40(a)(2)
  • 21 CFR 801
  • 21 CFR 803.17
  • 21 CFR 803
  • 21 CFR 807.81(a)(3)(i)
  • 21 CFR 807.81
  • 21 CFR 807.81(b)
  • 21 CFR 820.30(a)
  • 21 CFR 820.30(j)
  • 21 CFR 820.30(g)
  • 21 CFR 820.50(a)
  • 21 CFR 820.22
  • 21 CFR 820.198(a)
  • 21 CFR 830
  • 21 CFR 830.300(a)
  • 21 CFR 830.3
  • 21 CFR 878.4040