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

Source: https://www.keypedia.com/records/eir/allergan-sales-llc/615bcae8-7098-4de1-bf17-d09b74b9fa2d

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

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## Details

- Record Type: EIR
- Company Name: Allergan Sales LLC
- Inspection Date: 2019-07-29
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA surveillance Good Manufacturing Practice (GMP) inspection of Allergan Sales LLC in Cincinnati, OH, was conducted from June 3 to July 29, 2019. The inspection revealed significant compliance issues, primarily concerning their Armour Thyroid drug product. The main violations, documented on a 4-item FDA Form 483, included a repeated failure to thoroughly investigate unexplained discrepancies, particularly for out-of-specification (OOS) potency results of Armour Thyroid. The company frequently invalidated OOS results without conducting comprehensive manufacturing investigations or reaching scientifically sound conclusions. Additionally, OOS results were not detected in a timely manner, preventing confirmatory testing, and investigations often exceeded established deadlines. Allergan also failed to establish scientifically sound and appropriate specifications for Armour Thyroid’s internal potency release limits. These specifications were altered multiple times based on historical data rather than a clear understanding of manufacturing variability or the impact of tablet weight. Furthermore, the inspection noted a failure to establish control procedures to validate manufacturing process performance and to retest incoming thyroid powder API after long storage, lacking scientific justification for its re-assay period. Critically, the Armour Thyroid product itself was identified as an unapproved new drug. Regulatory guidelines for drug manufacturing, including those outlined in 21 CFR, formed the basis of these observations. Allergan's management acknowledged the observations and committed to submitting a written response within 15 business days, indicating they had begun a detailed review of the Armour Thyroid product.

## Related Documents

- [483 - 2019-07-29](https://www.keypedia.com/records/483/allergan-sales-llc/ceb2fcf9-0fce-47ca-bfcf-d777df2bf1e0)
- [483 - 2021-06-24](https://www.keypedia.com/records/483/allergan-sales-llc/896ebafc-4223-4f11-b5c1-f03b7b9e564f)
- [EIR - 2021-06-24](https://www.keypedia.com/records/eir/allergan-sales-llc/86081f6e-b675-465d-abd2-7543aa811c20)
- [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