Drug factory · FDA FEI 3015204529
Aucta Pharmaceuticals, Inc.
71 Suttons Lane, Piscataway, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 3, 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 |
|---|---|---|---|
| Arformoterol | Labels it | Aucta Pharmaceuticals, Inc. | 73289-0072 |
| Deflazacort | Makes it and labels it | Aucta Pharmaceuticals, Inc. | 73289-0089 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 3, 2025 | 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 3, 2025 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Registered with FDA for: analysis; label; manufacture; pack.