Drug factory · FDA FEI 3002807274

Zambon Switzerland Ltd

Via Industria 13, Cadempino, Switzerland

Problems found, fixed voluntarily at FDA's last inspection, Dec 12, 2024.

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 2010: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Cilastatin and Imipenem	Makes it	Fresenius Kabi, LLC	63323-322, 63323-349
Meropenem	Makes it	Fresenius Kabi, LLC	63323-507, 63323-508

FDA inspection history

Ended	Result	Program	Problems noted
Dec 12, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 13, 2019	No problems found	Drug Quality Assurance	—
Feb 13, 2018	No problems found	Drug Quality Assurance	—
Mar 30, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	9
Dec 19, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 7, 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.

Mar 30, 2016 inspection

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
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.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
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.
Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the sampling of components.

Registered with FDA for: manufacture.