Drug factory · FDA FEI 3000978864
Novartis Pharma Produktions GmbH
Oeflinger Str. 44, Wehr, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 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 2011: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pimecrolimus | Makes it | Oceanside Pharmaceuticals. | 68682-110, 68682-111, 68682-112 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | No problems found | Drug Quality Assurance | — |
| May 19, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 18, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 15, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 15, 2011 inspection
- Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Registered with FDA for: analysis; label; manufacture; pack.