FDA establishment 3010164738, Pennsauken, New Jersey, United States. Part of AptaPharma Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Aug 14, 2026 | Drugs · Drug Quality Assurance | 2 cited references
| Voluntary Action Indicated (VAI) |
| Oct 24, 2024 | Drugs · Bioresearch Monitoring | None posted | No Action Indicated (NAI) |
| Sep 25, 2019 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Mar 16, 2018 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Jun 23, 2014 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Recalled product | Class | Classified |
|---|---|---|
| Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co.…Drug · D-0787-2022 | Class III | Mar 29, 2022 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
Pennsauken, New Jersey, United States. Part of