Drug factory · FDA FEI 2650046
Warner Chilcott Company, LLC
Manati, Puerto Rico, 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, Oct 3, 2016.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2010: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ethinyl Estradiol and Norethindrone | Makes it, tests it and packages it | Lupin Pharmaceuticals, Inc. | 68180-898, 68180-899 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 3, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Oct 30, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 5, 2010 | 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.
Oct 3, 2016 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Written distribution procedure 21 CFR 211.150
Written distribution procedures are not followed. - Sampling and testing plans not described 21 CFR 211.165(c)
Sampling and testing plans for drug products are not described in written procedures which include the method of sampling. - Cleaning SOPs/schedules 21 CFR 211.67(b)(2)
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.