Drug factory · FDA FEI 3007687501

Haupt Pharma Latina Srl

STRADA REGIONALE 156 DEI MONTI LEPINI, Borgo San Michele, Italy

Problems found, fixed voluntarily at FDA's last inspection, Apr 11, 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: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Piperacillin and Tazobactam	Makes it, tests it and packages it	Fresenius Kabi, LLC	63323-981, 63323-982, 63323-983

Ended	Result	Program	Problems noted
Apr 11, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 29, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 28, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	5
Dec 16, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 4, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	6
Dec 12, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 13, 2009	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

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 and written.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to reject all drug product containers and closures.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.

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.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not documented at the time of performance.
Washing and toilet facilities are deficient 21 CFR 211.52
Washing and toilet facilities lack hot and cold water.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: analysis; manufacture; pack.