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FDA Warning Letter Explorer
FDA warning letter · Drugs

Osmosis, 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

You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, you informed our investigator that you did not have any written procedures for quality control operations.

Passage 2

You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you do not have written procedures for reviewing and investigating product complaints. Once you establish written procedures for the requirements of product complaints, you must include all the requirements in accordance 21 CFR 111.560.

Passage 3

You failed to establish and follow written procedures to fulfill the requirements that apply to returned dietary supplements, including the procedures for conducting a material review and making a disposition decision, in accordance with 21 CFR 111.503. Specifically, during the inspection you confirmed that you have no written procedures for handling returned products.

Passage 4

Your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, during the inspection you confirmed that have no written procedures for the holding and distribution of your dietary supplement products.

Citations in the original letter

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

  • 21 CFR 101.36(b)(2)(i)
  • 21 CFR 101.36(b)(2)(iii)(B)
  • 21 CFR 101.9(b)
  • 21 CFR 101.12(b)
  • 21 CFR 101.36
  • 21 CFR 101.9(c)(2)
  • 21 CFR 101.36(c)(2)
  • 21 CFR 101.9(c)
  • 21 CFR 101.36(b)(2)(iii)(E)
  • 21 CFR 101.36(e)(1)
  • 21 CFR 101.36(b)(3)(ii)(A)
  • 21 CFR 101.3(d)
  • 21 CFR 101.93
  • 21 CFR 111.103
  • 21 CFR 111.25(c)
  • 21 CFR 111.27(d)
  • 21 CFR 111.35(a)
  • 21 CFR 111.553
  • 21 CFR 111.560
  • 21 CFR 111.503
  • 21 CFR 111.535(b)
  • 21 CFR 111.453
  • 21 CFR 111.475(b)(1)
  • 21 CFR 111
  • 21 CFR 201.5
  • 21 CFR 21