Drug factory · FDA FEI 3001451826
Swiss-American CDMO, LLC
2055 Luna Rd., Suite 126, Carrollton, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 31, 2022.
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 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydroquinone and Octinoxate and Zinc Oxide | Makes it | Omp, Inc. | 62032-500 |
| Hydroquinone and Titanium Dioxide and Zinc Oxide | Makes it | Omp, Inc. | 62032-918 |
| Hydroquinone, Homosalate, Octisalate and Zinc Oxide | Makes it | Omp, Inc. | 62032-529, 62032-531, 62032-532 +6 |
| Salicylic Acid | Makes it, tests it, packages it and labels it | Elorac Inc. | 42783-323, 42783-324 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 31, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Dec 12, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 4, 2015 | No problems found | Drug Quality Assurance | — |
| Mar 1, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 11, 2010 | No problems found | Drug Quality Assurance | — |
| Jul 27, 2009 | 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.
Mar 31, 2022 inspection
- Subdivided component container identification 21 CFR 211.101(b)(1)
Containers holding subdivided components for drug product manufacturing are deficiently identified in that they lack the component name and item code. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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. - 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them. - Rejected Material Area 21 CFR 211.42(c)(2)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components and drug product containers before disposition. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance and parameters relevant to the operation.
Registered with FDA for: manufacture.