Drug factory · FDA FEI 1011574
Greer Laboratories, Inc.
639 Nuway Circle, NE, PO Box 800, Lenoir, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 12, 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 2010: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 12, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 15, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 29, 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.
Dec 12, 2025 inspection
- 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, written and followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: manufacture.