FDA Inspection 780144 — Organics Corporation of America
The FDA completed an inspection of Organics Corporation of America on May 7, 2012 in Totowa, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Totowa, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15848 | 21 CFR 111.73 | Specifications met - component purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |