Drug factory · FDA FEI 1825662
AstraZeneca Pharmaceuticals LP
4601 Highway 62 East, Mount Vernon, IN, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 19, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dapagliflozin and Metformin | Makes it, tests it and packages it | Prasco Laboratories | 66993-361, 66993-362 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jan 28, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 12, 2011 | No problems found | Drug Quality Assurance | — |
| Feb 3, 2010 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2009 | No problems found | 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.
Sep 19, 2023 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Oct 28, 2011 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not followed that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch.
Registered with FDA for: analysis; label; manufacture; pack.