FDA Inspection 1058777 — Oakmont Products, LLC
The FDA completed an inspection of Oakmont Products, LLC on Jul 13, 2018 in Lincoln, NE. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 13, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Over-the-Counter Drug Evaluation
- Location
- Lincoln, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |