Drug factory · FDA FEI 3009651112
The Johns Hopkins University
3400 N CHARLES ST, Baltimore, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 19, 2024.
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 2013: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ammonia N-13 | Makes it | The Johns Hopkins University | 40089-113 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 2, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 10, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
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 19, 2024 inspection
- Oversight of production operations 21 CFR 212.20(a)
You did not oversee production operations in a manner to ensure that each PET drug meets the quality and purity characteristics that it is supposed to have. - Examine, approve or reject 21 CFR 212.20(b)
You did not examine and approve or reject components to ensure compliance with procedures and specifications affecting the identity, strength, quality, or purity of a PET drug. - Equipment procedures 21 CFR 212.30(b)
You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is cleaned that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.
Sep 2, 2016 inspection
- Equipment procedures overall 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is properly installed and maintained. - Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component. - List of components 21 CFR 212.50(b)(3)
Your master production and control records did not contain a complete list of components designated by names and codes sufficiently specific to indicate any special quality characteristic.
Registered with FDA for: positron emission tomography drug production.