Drug factory · FDA FEI 1000166776
SmithKline Beecham Limited
Worthing, United Kingdom
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Serious problems, FDA action at FDA's last inspection, Jul 10, 2015.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
6 drug inspections on record since 2011: 0 with no problems, 1 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amoxicillin and Clavulanic Acid | Makes the active ingredient and tests it | Dr. Reddy's Laboratories Inc. | 43598-003, 43598-004, 43598-006 +10 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 10, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jul 10, 2015 | Serious problems, FDA action | Drug Quality Assurance | — |
| Oct 19, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 19, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 18, 2011 | Serious problems, FDA action | Drug Quality Assurance | — |
| Mar 18, 2011 | Serious problems, FDA action | 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.
Oct 19, 2012 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.