GENTELL — FDA Facility Profile
GENTELL is an FDA-registered facility (FEI 1000522686) located in Bristol, PA, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Sep 16, 2026: No Action Indicated (NAI)
- Inspections on record
- 4 (1 OAI, 1 VAI, 2 NAI)
- Last OAI inspection
- Aug 25, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Oct 5, 2015
- Recalls as the recalling firm
- 4, latest Mar 26, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 16, 2026 | No Action Indicated (NAI) | No citations listed |
| Dec 12, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) Quality Audit/Reaudit - conducted (21 CFR 820.22) Management representative (21 CFR 820.20(b)(3)) Management review - defined interval, sufficient frequency (21 CFR 820.20(c)) and 4 more |
| Dec 13, 2016 | No Action Indicated (NAI) | Supervisor Training/Education/Experience (21 CFR 211.25(b)) Procedures for non-sterile drug products (21 CFR 211.113(a)) Component identity verification (21 CFR 211.84(d)(1)) Testing and release for distribution (21 CFR 211.165(a)) and 7 more |
| Aug 25, 2015 | Official Action Indicated (OAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) and 13 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 26, 2020 | Class II | Z-1907-2020 | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing… and 3 more products During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Feb 27, 2020 | Class II | Z-1623-2020 | Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a… and 3 more products During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Apr 19, 2017 | Class II | D-0866-2017 | Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g… GMP Deviations; product may not meet cGMP requirements |
| Dec 15, 2016 | Class II | D-0242-2017 | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and… and 1 more product CGMP Deviations |
Facility details
- Company
- Gentell, Inc
- Location
- Bristol, PA (US)
- Source
- device