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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Spectra Therapy, LLC

Issued · Posted by FDA

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 procedures to control the design of the device in order to ensure that specified design requirements are met to demonstrate that the design was developed in accordance with the design control requirements as required by 21 CFR § 820.30(a) through § 820.30(j). Specifically,

Passage 2

Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100.

Passage 3

Failure to maintain an adequate record of investigation as required by 21 CFR § 820.198(e). The record of investigation shall include:

Passage 4

Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented, as required by 21 CFR § 820.50(a)(1).

Passage 5

Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR § 820.80(d).

Passage 6

Failure to establish procedures for quality audits and conduct such 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 7

Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives, as required by 21 CFR § 820.20(c).

Passage 8

Failure to establish and maintain procedures to control all documents, as required by 21 CFR § 820.40.

Passage 9

Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented, as required by 21 CFR § 820.25(b).

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
  • 21 CFR 803
  • 21 CFR 803.17
  • 21 CFR 803.17(a)(1)
  • 21 CFR 803.3
  • 21 CFR 803.50(a)
  • 21 CFR 803.17(a)(2)
  • 21 CFR 803.50(b)(3)
  • 21 CFR 803.17(a)(3)
  • 21 CFR 803.12(a)
  • 21 CFR 803.17(b)
  • 21 CFR 807.81(b)
  • 21 CFR 820.30(a)
  • 21 CFR 820.90
  • 21 CFR 820.100
  • 21 CFR 820.198(e)
  • 21 CFR 820.50(a)(1)
  • 21 CFR 820.80(d)
  • 21 CFR 820.22
  • 21 CFR 820.20(c)
  • 21 CFR 820.40
  • 21 CFR 820.25(b)
  • 21 CFR 830
  • 21 CFR 830.300(a)
  • 21 CFR 830.3
  • 21 CFR 890.5500
  • 21 CFR 890.9(a)