FDA Inspection 877539 — Ceba-Tek, Inc.
The FDA completed an inspection of Ceba-Tek, Inc. on April 25, 2014 in Melbourne, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15970 | 21 CFR 111.120 | Quality control operations - components, packaging, labels |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |