Drug factory · FDA FEI 1818977
Par Health USA, LLC
870 Parkdale Road, Rochester, MI, United States
Serious problems, FDA action at FDA's last inspection, Oct 20, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
13 drug inspections on record since 2009: 1 with no problems, 11 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Epinephrine | Makes it | ENDO USA, Inc. | 42023-159 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 20, 2025 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Apr 14, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 15, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 28, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 28, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 8, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Aug 31, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 18, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 17, 2009 | Problems found, fixed voluntarily | 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.
Oct 20, 2025 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. - 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. - 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.
Apr 14, 2023 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
Apr 15, 2019 inspection
- Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
Mar 13, 2017 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.