Drug factory · FDA FEI 3027022725
Wellbeing Medical Supply
3151 Airway Ave Ste I2, Costa Mesa, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2025: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Benzalkonium and Furosemide | Packages it | Wellbeing Medical Supply | 83315-100, 83315-200 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 25, 2025 inspection
- Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labels, labeling and packaging materials are used for drug products are not written. - Records not made readily available to FDA 21 CFR 211.180(c)
Records associated with drug product production and distribution and within the retention period for such records, were not made readily available for authorized inspection. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Registered with FDA for: pack.