Drug factory · FDA FEI 2510692
Bayer Healthcare LLC
400 W Stoever Ave, Myerstown, PA, United States
No problems found at FDA's last inspection, May 22, 2026.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Primaquine | Makes it, tests it, packages it and labels it | Sanofi-Aventis U.S. LLC | 0024-1596 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 22, 2026 | No problems found | Drug Quality Assurance | — |
| Jun 7, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 11, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 21, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 22, 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.
Aug 11, 2017 inspection
- Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack; repack.