FDA Inspection 1107689 — Next Science, LLC
The FDA completed an inspection of Next Science, LLC on October 25, 2019 in Jacksonville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |