FDA Inspection 868773 — Markmann Nutraceuticals, Inc.
The FDA completed an inspection of Markmann Nutraceuticals, Inc. on Mar 4, 2014 in Tempe, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tempe, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15452 | 21 CFR 111.15(f)(5) | Plumbing - backflow, cross connection |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15847 | 21 CFR 111.73 | Specifications met - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15982 | 21 CFR 111.123(a)(6) | Quality control operations - in-process specifications |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 15991 | 21 CFR 111.127(a) | Quality control operations - labeling; visual examinations |
| 15995 | 21 CFR 111.127(d) | Quality control operations - packaged, labeled; specifications |