FDA Inspection 1101425 — Global Biotechnologies, Inc.
The FDA completed an inspection of Global Biotechnologies, Inc. on September 6, 2019 in Portland, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 6, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Portland, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |
| 18148 | 21 CFR 117.37 | Sanitary facilities and controls |