Guna Inc. — FDA Facility Profile
Guna Inc. is an FDA-inspected facility (FEI 3007894121) located in Whitehall, PA, US. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Dec 23, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Jan 11, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 23, 2019 | Voluntary Action Indicated (VAI) | Written procedures - holding (21 CFR 111.453) Records - product distribution (21 CFR 111.475(b)(2)) |
| Aug 5, 2010 | Voluntary Action Indicated (VAI) | Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Written calibration / inspection records not kept (21 CFR 211.68(a)) Complaint Handling Procedure (21 CFR 211.198(a)) Written sanitation procedures lacking (21 CFR 211.56(b)) and 2 more |
Facility details
- Company
- Guna Inc.
- Location
- Whitehall, PA (US)
- Source
- inspections