Guna-Spa — FDA Facility Profile
Guna-Spa is an FDA-registered facility (FEI 3004443273) located in Milano, MI, IT. Registered operations: MANUFACTURE. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- May 16, 2014: Official Action Indicated (OAI)
- Inspections on record
- 1 (1 OAI)
- Last OAI inspection
- May 16, 2014
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Nov 15, 2010
- Import refusals
- 8
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 16, 2014 | Official Action Indicated (OAI) | Failure to include one of special control procedures (21 CFR 211.122(g)) Annual visual exams of drug products (21 CFR 211.170(b)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 15, 2010 | Class II | D-780-2011 | GUNA biotherapeutics/GUNA(R)-COLLAGEN Homeopathic medicine and 15 more products CGMP Deviations: FDA inspection at manufacturer revealed cGMP deviations. |
Facility details
- Company
- Guna S.P.A.
- Location
- Milano, MI (IT)
- Registration Expires
- Dec 31, 2027
- Operations
- MANUFACTURE
- Source
- decrs