Drug factory · FDA FEI 2517175
PPL Healthcare LLC
650 CATHILL RD, Sellersville, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, May 8, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2008: 1 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atovaquone | Makes it | Glenmark Pharmaceuticals Inc., USA | 68462-421 |
| Sucralfate | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-827 |
| Zinc Cation | Makes it, packages it and labels it | Eton Pharmaceuticals, Inc. | 71863-124, 71863-125 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 8, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 13, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 3, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 5, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 28, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2008 | 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.
May 8, 2026 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Apr 24, 2018 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Registered with FDA for: analysis; label; manufacture; pack.