FDA Inspection 1120795 — Walfer Corporation dba Wallace Pharmacy
The FDA completed an inspection of Walfer Corporation dba Wallace Pharmacy on March 16, 2020 in Port Charlotte, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 16, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Charlotte, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18933 | FDCA 501(a)(2)(A) | Vermin, production area |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18943 | FDCA 501(a)(2)(A) | Personnel in aseptic processing, non-sterile gloves |
| 18944 | FDCA 501(a)(2)(A) | Exposure of personnel in aspectic processing |
| 18945 | FDCA 501(a)(2)(A) | Aseptic processing outside ISO 5 area |
| 18950 | FDCA 501(a)(2)(A) | Personnel contact on container or closure |
| 18955 | FDCA 501(a)(2)(A) | Ceiling tiles, cleanroom |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18960 | FDCA 501(a)(2)(A) | Flow of personnel and materials, facility |
| 18962 | FDCA 501(a)(2)(A) | Lack of HEPA filter, sterile product area |
| 18965 | FDCA 501(a)(2)(A) | Sinks, drains in cleanroom of ISO 5 area |
| 18968 | FDCA 501(a)(2)(A) | Inadequate filter, final product sterilization |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |
| 18971 | FDCA 501(a)(2)(A) | No sporicidal agents, cleanroom and ISO 5 area |