Warner Chilcott Company, LLC
Overview
Warner Chilcott, now part of Allergan, was known for developing and marketing pharmaceutical products primarily in the women's health and dermatology sectors. As a subsidiary of Allergan, it continues to contribute to the parent company's expansive portfolio in specialty pharmaceuticals.
Therapeutic areas
FDA compliance signals
10 FDA enforcement records linked to this company.
- 4832016-10-03
Cleaning SOPs/schedules
- 4832016-10-03
SOPs not followed / documented
- 4832016-10-03
Written distribution procedure
- 4832016-10-03
Sampling and testing plans not described
- recall — Class II2013-08-07
Failed Impurities/Degradation Specifications: unspecified degradation product
- recall — Class III2013-05-08
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- recall — Class III2013-05-08
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- recall — Class III2013-05-08
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
- recall — Class III2013-02-06
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
- recall — Class III2013-02-06
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
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