First Quality Hygienic, Inc. FDA Record
First Quality Hygienic, Inc. has 0 FDA recalls, 1 inspection, 11 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "First Quality Hygienic, Inc." is on file.
- Latest inspection
- May 7, 2014 · NAI
- Latest 510(k)
- Aug 5, 2016
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing First Quality Hygienic, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check First Quality Hygienic, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 7, 2014 | Mc Elhattan, PA | Devices | No Action Indicated (NAI) | 1000121333 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000121333 | Mc Elhattan, PA | 1 | May 7, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by… | Aug 5, 2016 |
| K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by… | Nov 2, 2015 |
| K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | Jul 14, 2005 |
| K050660 | FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | May 12, 2005 |
| K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | Feb 1, 2005 |
| K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | Sep 3, 2003 |
| K031067 | FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS | Jul 14, 2003 |
| K023479 | FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK… | Nov 26, 2002 |
| K963034 | FEMTEX GENTLE TOUCH TAMPONS | Nov 1, 1996 |
| K963032 | FREE CHOICE | Oct 11, 1996 |
| K920238 | PRIVATE LABELS AND FEMTEX | Aug 2, 1993 |
First Quality Hygienic, Inc. and the FDA: common questions
Has First Quality Hygienic, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "First Quality Hygienic, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has First Quality Hygienic, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "First Quality Hygienic, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect First Quality Hygienic, Inc.?
The most recent FDA inspection on file ended May 7, 2014 at Mc Elhattan, PA and was classified NAI. FDA has 1 inspection of First Quality Hygienic, Inc. on file.
Need more than this page shows? Ask about First Quality Hygienic, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.