FDA Inspection 1101435 — Reliant Compounded Solutions Monroe, LLC
The FDA completed an inspection of Reliant Compounded Solutions Monroe, LLC on August 29, 2019 in Monroe, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 29, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monroe, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18937 | FDCA 501(a)(2)(A) | Beta-lactam drugs, inadequate sanitation |
| 18955 | FDCA 501(a)(2)(A) | Ceiling tiles, cleanroom |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18959 | FDCA 501(a)(2)(A) | Location, ISO 5 classified area |
| 18963 | FDCA 501(a)(2)(A) | Inadequate HEPA filter, sterile product area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |
| 18972 | FDCA 501(a)(2)(A) | Inadequate sporicidal agents, cleanroom and ISO 5 area |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |