Drug factory · FDA FEI 3003581732

Merck Serono Spa

Via delle Magnolie 15, Modugno (loc. frazione Zona Industriale), Italy

Problems found, fixed voluntarily at FDA's last inspection, Sep 26, 2025.

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

9 drug inspections on record since 2010: 0 with no problems, 9 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Pegfilgrastim	Makes it	Fresenius Kabi USA, LLC, Northstar Rx LLC.	65219-371, 72603-402
Tocilizumab	Makes it	Fresenius Kabi USA, LLC	65219-584, 65219-586, 65219-596 +1

Ended	Result	Program	Problems noted
Sep 26, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 17, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 31, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jun 22, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 25, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	2
May 10, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jul 1, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	5
Sep 25, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jul 16, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Representative Samples Criteria 21 CFR 211.84(b)
The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria.

Acceptance of drug products 21 CFR 211.160(b)(3)
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
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.

Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of packaging of the drug product.
Review of problem drugs 21 CFR 211.180(e)(2)
The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of complaint records for each drug product.
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.
Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.

Registered with FDA for: analysis; label; manufacture; pack.