Drug factory · FDA FEI 2517100
AstraZeneca Pharmaceuticals LP
587 Old Baltimore Pike, Newark, DE, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 26, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dapagliflozin and Metformin | Packages it | Prasco Laboratories | 66993-361, 66993-362 |
| Vandetanib | Packages it and labels it | Genzyme Corporation | 58468-7820, 58468-7840 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 26, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 19, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 27, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 28, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 5, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 10, 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.
Jun 26, 2026 inspection
- Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Aug 24, 2017 inspection
- Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Aug 27, 2014 inspection
- Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and instructions for protection of clean equipment from contamination prior to use.
Jul 5, 2011 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Registered with FDA for: analysis; label; manufacture; pack.