Drug factory · FDA FEI 1038197
Generics Bidco II LLC d/b/a Prinston Laboratories
3700A Woodpark Blvd., Charlotte, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 19, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
20 drug inspections on record since 2010: 8 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Allopurinol | Makes it and tests it | ENDO USA, Inc. | 0603-2115, 0603-2116 |
| Perphenazine | Makes it and tests it | Par Health USA, LLC | 0603-5060, 0603-5061, 0603-5062 +1 |
| Phenobarbital | Makes it and tests it | ENDO USA, Inc. | 0603-5165, 0603-5166, 0603-5167 +1 |
| Prednisone | Makes it and tests it | Par Health USA, LLC | 0603-5335, 0603-5336, 0603-5337 +2 |
| Trihexyphenidyl | Makes it and tests it | Richmond Pharmaceuticals, Inc. | 54738-554, 54738-555 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 19, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Sep 19, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 11, 2020 | No problems found | Drug Quality Assurance | — |
| Mar 11, 2020 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 24, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 24, 2016 | No problems found | Drug Quality Assurance | — |
| Apr 9, 2015 | No problems found | Drug Quality Assurance | — |
| Apr 9, 2015 | No problems found | Drug Quality Assurance | — |
| May 7, 2014 | No problems found | Drug Quality Assurance | — |
| May 7, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 14, 2014 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 14, 2014 | Serious problems, FDA action | Drug Quality Assurance | — |
| Aug 10, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 10, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 9, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 9, 2011 | No problems found | Drug Quality Assurance | — |
| Apr 15, 2010 | No problems found | Drug Quality Assurance | — |
| Apr 15, 2010 | 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.
Sep 19, 2025 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. - 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. - 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. - 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; manufacture.