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FDA Warning Letter Explorer
FDA warning letter · Drugs

Golden Lab LLC

Issued · Posted by FDA

FDA published a close-out letter on Apr 3, 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

You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).

Passage 2

Your batch production records (BPRs) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260.

Citations in the original letter

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

  • 21 CFR 111.75(c)
  • 21 CFR 111.70(e)
  • 21 CFR 111.70(b)(2)
  • 21 CFR 111.70
  • 21 CFR 111.73
  • 21 CFR 111.75(a)(1)(i)
  • 21 CFR 111.75(a)(1)(ii)
  • 21 CFR 111.70(b)
  • 21 CFR 111.75(a)(2)
  • 21 CFR 111.95
  • 21 CFR 111.255(b)
  • 21 CFR 111.260
  • 21 CFR 111.260(j)
  • 21 CFR 111
  • 21 CFR 201.5