Drug factory · FDA FEI 3002807114
GlaxoSmithKline Manufacturing SpA
Strada Provinciale 343 Asolana 90, Torrile, San Polo, Italy
Problems found, fixed voluntarily at FDA's last inspection, Oct 26, 2023.
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 2011: 4 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Haloperidol | Makes it and tests it | Janssen Pharmaceuticals, Inc., Patriot Pharmaceuticals | 50458-253, 50458-254, 10147-0921 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 26, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 29, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 22, 2016 | No problems found | Drug Quality Assurance | — |
| May 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Jul 10, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 21, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 28, 2011 | 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.
May 27, 2015 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - 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 followed. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. - Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of production associated with a batch of drug product are not maintained at least one (1) year after the expiration date. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling, and drug products. - 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. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; sterilize.