FDA Inspection 1110847 — McGuff Pharmaceuticals, Inc.
The FDA completed an inspection of McGuff Pharmaceuticals, Inc. on November 22, 2019 in Santa Ana, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18960 | FDCA 501(a)(2)(A) | Flow of personnel and materials, facility |
| 18964 | FDCA 501(a)(2)(A) | Unsealed HEPA filter, perimeter |
| 18972 | FDCA 501(a)(2)(A) | Inadequate sporicidal agents, cleanroom and ISO 5 area |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |