Drug factory · FDA FEI 3003673570
Sharp Clinical Services, LLC
2400 Baglyos Circle, Bethlehem, PA, United States
No problems found at FDA's last inspection, Aug 29, 2024.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Capsaicin | Packages it and labels it | Averitas Pharma, Inc. | 72512-928, 72512-929, 72512-930 |
| Elamipretide | Packages it and labels it | Stealth Biotherapeutics Inc. | 72507-800 |
| Phenylbutyric Acid | Packages it | Acer Therapeutics Inc. | 72542-200, 72542-300, 72542-400 +3 |
| Sirolimus | Tests it, packages it and labels it | Nobelpharma America, LLC | 73683-101 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 29, 2024 | No problems found | Drug Quality Assurance | — |
| Sep 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 30, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 27, 2015 | No problems found | Drug Quality Assurance | — |
| Apr 20, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 14, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 14, 2009 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations. - Incoming material area 21 CFR 211.42(c)(1)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components and drug product containers pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.