Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection the investigator requested your MMRs for Colostrum-5 Capsules and Colostrum-5 Powder, and you stated that you did not have an MMR.
Passage 2You failed to include necessary information in the batch production records (BPRs), as required in 21 CFR 111.260. Specifically, your “Colostrum **(b)(4)** Reports,” which you provided as your BPRs for your Colostrum-5 Capsules and your Colostrum-5 Powder, are missing the following required information:
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 111.73
- 21 CFR 111.260
- 21 CFR 111.113(b)(1)
- 21 CFR 111.70(b)
- 21 CFR 111.205(a)
- 21 CFR 111.210(a)
- 21 CFR 111.210(b)
- 21 CFR 111.210(c)
- 21 CFR 111.210(d)
- 21 CFR 111.210(e)
- 21 CFR 111.210(f)
- 21 CFR 111.210(g)
- 21 CFR 111.210(h)(1)
- 21 CFR 111.210(h)(2)
- 21 CFR 111.210(h)(3)
- 21 CFR 111.210(h)(3)(i)
- 21 CFR 111.210(h)(3)(ii)(A)
- 21 CFR 111.210(h)(3)(ii)(B)
- 21 CFR 111.210(h)(4)
- 21 CFR 111.210(h)(5)
- 21 CFR 111.260(d)
- 21 CFR 111.260(e)
- 21 CFR 111.260(h)
- 21 CFR 111.260(i)
- 21 CFR 111.260(k)
- 21 CFR 111.260(l)(3)
- 21 CFR 111
- 21 CFR 201.5