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FDA Warning Letter Explorer
FDA warning letter · Drugs

MCACO, LTD

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 master manufacturing records (MMRs) that include all required components of 21 CFR 111.210. Specifically, your master manufacturing records for **(b)(4)** (120 Capsules) and **(b)(4)** (60 Capsules) failed to include:

Citations in the original letter

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

  • 21 CFR 111.70(e)
  • 21 CFR 111.70(b)(2)
  • 21 CFR 111.75(a)(2)(ii)(A)
  • 21 CFR 111.320(a)
  • 21 CFR 111.210
  • 21 CFR 111.210(d)
  • 21 CFR 111.210(g)
  • 21 CFR 111.210(h)(3)
  • 21 CFR 111.315(d)
  • 21 CFR 111.113(c)
  • 21 CFR 111.260(m)
  • 21 CFR 111