FDA Inspection 1181414 — Vital Care Compounder, Inc
The FDA completed an inspection of Vital Care Compounder, Inc on October 13, 2022 in Hattiesburg, MS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 13, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hattiesburg, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |
| 18950 | FDCA 501(a)(2)(A) | Personnel contact on container or closure |
| 18953 | FDCA 501(a)(2)(A) | Actionable microbial contamination, ISO 5 area |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18967 | FDCA 501(a)(2)(A) | Final/intermediate container and closure, sterile drug product |
| 18969 | FDCA 501(a)(2)(A) | Insufficient cycle parameters, heat sterilization of product |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |