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 establish specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.70. Specifically:
Passage 2You failed to prepare a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured and for each batch size of a dietary supplement that you manufactured, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection, your management explained that master manufacturing records had not been created for your Calcium or Magnesium supplements, or any of your other dietary supplements.
Passage 3You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83. Specifically, during the inspection, your management stated that you do not collect and hold reserve samples for any of the finished dietary supplements you distribute, including your Calcium and Magnesium supplements.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 111.70
- 21 CFR 111.70(b)(1)
- 21 CFR 111.70(b)(2)
- 21 CFR 111.70(d)
- 21 CFR 111.70(e)
- 21 CFR 111.73
- 21 CFR 111.205(a)
- 21 CFR 111.255(b)
- 21 CFR 111.260
- 21 CFR 111.103
- 21 CFR 111.65
- 21 CFR 111.83
- 21 CFR 111
- 21 CFR 201.5