FDA Inspection 1215708 — Reliant Compounded Solutions Monroe, LLC
The FDA completed an inspection of Reliant Compounded Solutions Monroe, LLC on August 23, 2023 in Monroe, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monroe, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22742 | FDCA 501(a)(2)(A) | Exposed to lower quality air/ISO 5 |
| 22743 | FDCA 501(a)(2)(A) | Personnel moving quickly, disrupting unidirectional airflow |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |