Drug factory · FDA FEI 3017953815
Ionetix Corporation
2760 SW 97TH Ave Ste B-109, Miami, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, May 1, 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 |
|---|---|---|---|
| Ammonia N-13 | Makes it | Ionetix Corporation | 71162-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 1, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 1, 2025 inspection
- Lack Adequate Resources, Facilities, Equipment. 21 CFR 212.10
You lack adequate resources to enable your personnel to perform their functions. - Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Equipment procedures 21 CFR 212.30(b)
You did not to ensure that all equipment is properly installed, maintained, and capable of repeatedly producing valid results 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. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not suitable for their intended use, sufficiently sensitive, sufficiently specific, sufficiently accurate and sufficiently reproducible. - Correction of problems 21 CFR 212.71(c)
You did not take appropriate action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.
Registered with FDA for: positron emission tomography drug production.