Drug factory · FDA FEI 3007041220
Linde Puerto Rico B.V.
Calle Mendez Vigo 171 Oeste, Mayaguez, PR, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 29, 2015.
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 2015: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Linde Puerto Rico B.V. | 11324-721 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 29, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 29, 2015 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing and holding of a drug product lack the training required to perform their assigned functions. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the maintenance of equipment.
Registered with FDA for: manufacture.