Drug factory · FDA FEI 3014335379
Biomedics Systems, Inc.
Rd 176 KM5.8A, San Juan, PR, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 4, 2019.
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 2019: 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 | Biomedics Systems, Inc. | 72574-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 4, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 4, 2019 inspection
- Determination of conformance 21 CFR 211.160(b)(1)
Determinations of conformance to appropriate written specifications for acceptance are deficient in that they are not made for each lot within each shipment of components and drug product containers used in the manufacture, processing, packing or holding of drug products.
Registered with FDA for: manufacture.