# FDA 483 - Actavis Laboratories FL, Inc. - May 25, 2021

Source: https://www.keypedia.com/records/483/actavis-laboratories-fl-inc/2670fdae-0b75-4049-a5ee-0826fd79c779

> FDA 483 for Actavis Laboratories FL, Inc. on May 25, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Actavis Laboratories FL, Inc.
- Inspection Date: 2021-05-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Actavis Laboratories FL, Inc. in Davie, FL, received a Form 483 with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality control investigations, including inadequate root cause analysis and product impact assessments for out-of-specification results. Additional issues included a lack of microbial testing for certain non-sterile drug products, failure to maintain equipment calibration, incomplete master batch records, and deficient procedures for handling customer complaints.

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## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/actavis-laboratories-fl-inc/6c959344-9e81-4c3c-9e6d-580e25151c7d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6