In a letter dated November 15, FDA states that, during a recent inspection of its facilities, the company:
- “failed to prepare and follow a written master manufacturing record (MMR)”,
- “failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement for each dietary supplement that you manufacture”,
- “failed to make and keep written records for the production and process control system requirements that apply to components, packaging, and labels”,
- and six other areas of good manufacturing practice (GMP).
In addition, the Agency noted that three of the company’s products were “misbranded […] because the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements.”