| CFR # | Description | # Obs. |
|---|---|---|
| 21 CFR 111.70(e) | Specifications – identity, purity, strength, composition | 92 |
| 21 CFR 111.103 | Written procedures – quality control operations | 73 |
| 21 CFR 111.553 | Written procedures – product complaint | 63 |
| 21 CFR 111.75(c) | Specifications met – verify; finished batch | 61 |
| 21 CFR 111.75(a)(2)(ii)(A) | Component – qualify supplier | 50 |
| 21 CFR 111.205(a) | Master manufacturing record – each batch | 50 |
| 21 CFR 111.255(b) | Batch record – complete | 47 |
| 21 CFR 111.453 | Written procedures – holding | 46 |
| 21 CFR 111.75(a)(1)(i) | Component – verify identity, dietary ingredient | 45 |
| 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
44 |
Late last year FDA released inspection observations (483 citations) for FY 2017. The table above shows the top 10 dietary supplement (21 CFR Part 111 cGMP) inspection observations found during inspections in FY17. Significantly, failure to verify the identity of all dietary ingredients has now dropped to 9th place, down from 2nd place in FY 2016. Lack of established specifications for identity, purity, strength, and composition of finished dietary supplements continues to be a problem found at a large number of firms. Failing to establish written procedures for quality control operations moved up to #2. Subpart E observations (for Production and Process Control) together made up nearly 34% of the total observations by FDA inspectors, continuing the trend upward of the past few fiscal years.