# FDA 483 - Allergan Sales LLC - July 29, 2019

Source: https://www.keypedia.com/records/483/allergan-sales-llc/ceb2fcf9-0fce-47ca-bfcf-d777df2bf1e0

> FDA 483 for Allergan Sales LLC on July 29, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Allergan Sales LLC
- Inspection Date: 2019-07-29
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Allergan Sales LLC in Cincinnati was cited for significant deficiencies in its drug manufacturing operations, particularly concerning Armour® Thyroid. The inspection revealed inadequate investigation of out-of-specification results, unscientific laboratory specifications, and a lack of validated manufacturing processes. Additionally, the firm failed to properly retest components after long storage periods, indicating systemic quality control issues.

## Related Documents

- [483 - 2021-06-24](https://www.keypedia.com/records/483/allergan-sales-llc/896ebafc-4223-4f11-b5c1-f03b7b9e564f)
- [483 - 2025-12-12](https://www.keypedia.com/records/483/allergan-sales-llc/81ab42c7-3436-495a-b55d-597bc32ff62e)

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Lynnsey Renn](https://www.keypedia.com/people/lynnsey-renn/ddc54244-f682-4130-80bc-d1a083b959fc)

Company: https://www.keypedia.com/companies/allergan-sales-llc/cb212c1e-ac46-4323-8c3c-379a2fa7d3b2

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22