Drug factory · FDA FEI 3015156709
BPI Labs LLC
12393 S Belcher Rd, Ste 450, Largo, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2025: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alcohol | Makes it, tests it and labels it | Ajenat Pharmaceuticals LLC, BPI Labs, LLC | 82983-426, 54288-144 |
| Aminocaproic Acid | Labels it | BPI Labs, LLC | 54288-151 |
| Epinephrine | Makes it and tests it | BPI Labs, LLC | 54288-117, 54288-119, 54288-120 +2 |
| Fluorescein | Makes it and tests it | BPI Labs, LLC | 54288-179 |
| Hyoscyamine | Makes it, tests it and labels it | BPI Labs, LLC | 54288-111 |
| Methylene Blue Cation | Makes it, tests it and labels it | BPI Labs, LLC | 54288-147, 54288-159 |
| Naloxone | Makes it and tests it | BPI Labs, LLC | 54288-124 |
| Papaverine | Makes it and tests it | BPI Labs, LLC | 54288-142 |
| Phenobarbital | Makes it and tests it | BPI Labs, LLC | 54288-136, 54288-137 |
| Potassium Cation | Labels it | BPI Labs, LLC | 54288-125 |
| Tacrolimus | Labels it | BPI Labs, LLC | 54288-133, 54288-134, 54288-135 |
| Testosterone | Makes it and tests it | Ajenat Pharmaceuticals LLC | 82983-424, 82983-425 |
| Tetracaine | Makes it and labels it | BPI Labs, LLC | 54288-127 |
| Trimethobenzamide | Makes it, tests it and labels it | BPI Labs, LLC | 54288-158 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 23, 2025 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Apr 23, 2025 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Feb 21, 2025 | No problems found | 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.
Apr 23, 2025 inspection
- Failure to comply with REMS Elements to Assure Safe Use (ETASU) A FDCA 505-1(f)(3)(A)
An application holder did not ensure mechanisms are in place that allow healthcare providers (HCPs) the ability to complete the certification process, as required by your approved REMS Element to Assure Safe Use (ETASU) A. - Failure to comply with REMS Elements to Assure Safe Use (ETASU) A FDCA 505-1(f)(3)(A)
An application holder did not ensure mechanisms are in place that allow healthcare providers (HCPs) the ability to complete the certification process, as required by your approved REMS Element to Assure Safe Use (ETASU) A.
Feb 21, 2025 inspection
- Drug product labels, fails to include FDCA 503B(a)(10)(A)
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Registered with FDA for: analysis; label; manufacture.