Keystone Rx LLC — FDA Facility Profile
Keystone Rx LLC is an FDA-inspected facility (FEI 3015119302) located in Bensalem, PA, US. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Jul 12, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 3 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 12, 2019 | Voluntary Action Indicated (VAI) | Non-microbial contamination, production area (FDCA 501(a)(2)(A)) |
Form 483s and inspection documents
- Mar 25, 2020: FMD-145 Letter on FDA.gov
- Mar 25, 2020: State Referral Letter on FDA.gov
- Jul 12, 2019: 483 on FDA.gov
Facility details
- Company
- Keystone Rx LLC
- Location
- Bensalem, PA (US)
- Source
- inspections