FDA Inspection
Walfer Corporation dba Wallace PharmacyWalfer Corporation dba Wallace Pharmacy – FDA Inspection, Mar 16, 2020
Record Details
This FDA Inspection record concerns Walfer Corporation dba Wallace Pharmacy, with an inspection on March 16, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 16, 2020
- Product Type
- Drugs
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ID · 4ce44d3c-af03-4a82-8c2b-fbbcb183fbf3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1120795
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- Disinfecting and cleaning agents, ISO 5 area
- Personnel in aseptic processing, non-sterile gloves
- Exposure of personnel in aspectic processing
- Personnel contact on container or closure
- Aseptic processing outside ISO 5 area
- Sinks, drains in cleanroom of ISO 5 area
- No sporicidal agents, cleanroom and ISO 5 area
- Inadequate filter, final product sterilization
- Cleanliness, ISO-classified areas
- Ceiling tiles, cleanroom
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Other FDA inspections of Walfer Corporation dba Wallace Pharmacy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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