FDA Inspection 1215708 — Reliant Compounded Solutions Monroe, LLC
The FDA completed an inspection of Reliant Compounded Solutions Monroe, LLC on Aug 23, 2023 in Monroe, CT. 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 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 |