Drug factory · FDA FEI 1524067
Pharmacia Hepar LLC
160 Industrial Drive, Franklin, OH, United States
No problems found at FDA's last inspection, May 1, 2024.
No Action Indicated: inspectors found no objectionable conditions.
12 drug inspections on record since 2010: 10 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Heparin | Makes the active ingredient and tests it | Hospira, Inc., Pfizer Laboratories Div Pfizer Inc | 0409-2720, 0409-2721, 0409-2723 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 1, 2024 | No problems found | Drug Quality Assurance | — |
| Feb 23, 2017 | No problems found | Drug Quality Assurance | — |
| Sep 20, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 20, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 17, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 21, 2012 | No problems found | Drug Quality Assurance | — |
| Sep 8, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 14, 2011 | No problems found | Drug Quality Assurance | — |
| Oct 1, 2010 | No problems found | Drug Quality Assurance | — |
| Aug 18, 2010 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2010 | No problems found | Drug Quality Assurance | — |
| May 25, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 25, 2010 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Registered with FDA for: analysis; api manufacture.