Drug factory · FDA FEI 1610608
Kavis Pharma LLC
12720 Dairy Ashford Rd, Sugar Land, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 9, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 6 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fluorouracil | Makes it, tests it, packages it and labels it | Bausch Health US, LLC, Dr. Reddy's Laboratories Inc. | 0187-3202, 0187-3203, 0187-3204 +1 |
| Mafenide | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-723 |
| Nitroglycerin | Makes it | TruPharma LLC. | 52817-835 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 1, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 8, 2016 | No problems found | Drug Quality Assurance | — |
| May 22, 2015 | No problems found | Drug Quality Assurance | — |
| May 23, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 12, 2011 | No problems found | Drug Quality Assurance | — |
| Apr 9, 2009 | 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.
Apr 9, 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 and written. - Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems. - Systems in place to comply with verification requirements FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Registered with FDA for: analysis; label; manufacture; pack.