Drug factory · FDA FEI 2243092
Everest Life Sciences LLC
31 SCHALKS CROSSING RD, Plainsboro, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 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 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dapsone | Makes it, makes the active ingredient and tests it | Everest Life Sciences. LLC | 83098-101, 83098-102 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 23, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Oct 23, 2018 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jul 13, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 16, 2016 | No problems found | Drug Quality Assurance | — |
| Apr 16, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 18, 2011 | 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.
Apr 23, 2025 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity. - 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. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of equipment is not performed according to a written program designed to assure proper performance. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack; repack.