Drug factory · FDA FEI 3009566827
Sharp Packaging Services, LLC
7570 Industrial Park Way, Macungie, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadoquatrane | Labels it | Bayer HealthCare Pharmaceuticals Inc. | 50419-321, 50419-322, 50419-323 +8 |
| Methylphenidate | Packages it and labels it | Mayne Pharma Inc. | 51862-609, 51862-610, 51862-611 +2 |
| Tislelizumab | Packages it and labels it | BeOne Medicines USA, Inc. | 72579-121, 72579-125 |
| Zanubrutinib | Packages it and labels it | BeOne Medicines USA, Inc. | 72579-122 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 9, 2022 | No problems found | Drug Quality Assurance | — |
| Aug 16, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 10, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 25, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 10, 2012 | 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 12, 2025 inspection
- Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the packing of a drug product lack the training required to perform their assigned functions. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Aug 16, 2018 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.
Feb 25, 2014 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: label; pack; relabel; repack.