Drug factory · FDA FEI 3000203175
Wyandotte Welding Supply Inc.
Wyandotte, Michigan, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Apr 24, 2012.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2012: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Wyandotte Welding Supply Inc. | 63045-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 24, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 24, 2012 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch. - Adequate number of batches on stability 21 CFR 211.166(b)
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt, storage, and handling of components.