Drug factory · FDA FEI 3001698565
Span Packaging Services LLC dba Multi-Pack Solutions
1301 Perimeter Rd, Greenville, SC, United States
Problems found, fixed voluntarily at FDA's last inspection, May 2, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Benzoyl Peroxide | Makes it | PruGen, Inc. | 42546-016 |
| Hydrocortisone and Pramoxine | Makes it | Womens Choice Pharmaceuticals LLC | 50967-357 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 2, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 11, 2018 | No problems found | Drug Quality Assurance | — |
| May 1, 2014 | No problems found | Drug Quality Assurance | — |
| Aug 10, 2011 | 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.
May 2, 2025 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 established, written and followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate designed to assure that components conform to appropriate standards of identity, strength, quality and purity. - 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: manufacture; pack.