Drug factory · FDA FEI 3002808171

Alfasigma Spa

Via Pontina Km 30, 400, Pomezia, Italy

Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Levocarnitine	Makes it	Akorn	50383-172

FDA inspection history

Ended	Result	Program	Problems noted
Jan 26, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 28, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 21, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 10, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	7
Sep 16, 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.

Nov 10, 2015 inspection

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
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 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.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance.
Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of instruments not meeting established specifications was observed. Electronic records are used, but they do not meet authority check, personnel qualifications, and employee accountability/responsibility policy requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Clothing appropriate for duties performed 21 CFR 211.28(a)
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Registered with FDA for: manufacture.