# FDA 483 - Allergan Sales LLC - June 24, 2021

Source: https://www.globalkeysolutions.net/records/483/allergan-sales-llc/896ebafc-4223-4f11-b5c1-f03b7b9e564f

> FDA 483 for Allergan Sales LLC on June 24, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allergan Sales LLC
- Inspection Date: 2021-06-24
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Allergan Sales LLC in Cincinnati, OH, revealed significant deficiencies in laboratory controls, stability testing, and quality unit responsibilities related to their Armour® Thyroid drug product. The firm lost critical method validation data, failed to establish and follow adequate stability programs, and did not thoroughly investigate discrepancies or properly handle product complaints. Several observations were repeats from previous inspections, indicating persistent quality system issues.

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## Related Officers

- [Mathematical statistician](https://www.globalkeysolutions.net/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)
- [Investigator ](https://www.globalkeysolutions.net/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Drug Specialist](https://www.globalkeysolutions.net/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

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

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