Drug factory · FDA FEI 1000183111
Boehringer Ingelheim Promeco S.A. de C.V.
Maiz No. 49, Barrio Xaltocan, Xochimilco, Mexico City, Mexico
Problems found, fixed voluntarily at FDA's last inspection, May 20, 2022.
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 2013: 3 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrochlorothiazide and Telmisartan | Packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0042, 0597-0043, 0597-0044 |
| Linagliptin | Makes it, packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0140 |
| Linagliptin and Metformin | Makes it, tests it, packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0146, 0597-0147, 0597-0148 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 20, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 6, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| Dec 8, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 20, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 25, 2013 | 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 20, 2022 inspection
- Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality and purity of drug products. - Potable water standards not met 21 CFR 211.48(a)
The potable water being permitted for use in the potable water system fails to meet standards prescribed by the Environmental Protection Agency. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.