Drug factory · FDA FEI 3014641959
Laboratoire Aguettant
Champagne, France
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, Nov 6, 2018.
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 2018: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Potassium Cation | Makes it, tests it, packages it, labels it, relabels it and sterilizes it | Laboratoire Aguettant | 60710-015 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 6, 2018 inspection
- Acceptance of in-process materials 21 CFR 211.160(b)(2)
Determinations of conformance to appropriate written specifications for acceptance are deficient for in-process materials. - 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. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair. - Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
There was a failure to handle and store components at all times in a manner to prevent contamination. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.