FDA Inspection 1099595 — O.L. Products Inc.
The FDA completed an inspection of O.L. Products Inc. on Aug 14, 2019 in Oldsmar, FL. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oldsmar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |