FDA Inspection 1088858 — Marine Healthfoods Ltd
The FDA completed an inspection of Marine Healthfoods Ltd on April 2, 2019 in Aughrim. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Aughrim (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |