# FDA EIR - Allergan Sales, LLC - February 27, 2019

Source: https://www.keypedia.com/records/eir/allergan-sales-llc/093578ba-d845-4cf3-9593-cb92ccc6efe2

> FDA EIR for Allergan Sales, LLC on February 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Allergan Sales, LLC
- Inspection Date: 2019-02-27
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Allergan Sales, LLC's Waco, TX facility, a manufacturer of sterile ophthalmic drug products, was conducted from January 29 to February 27, 2019. This follow-up inspection assessed corrections made since a 2016 inspection which had resulted in an FDA-483 and an Untitled Letter; the previous deficiencies were found to be corrected. However, the current inspection revealed three new observations documented on an FDA-483. The main issues included a failure to adequately evaluate interventions during smoke studies for Multi Dose Line (b)(4), impacting procedures to prevent microbiological contamination (21 CFR 211.113(b)). There was also a deficiency in environmental monitoring, as a risk assessment did not evaluate a specific component within the Grade A area of Multi Dose Line (b)(4) (21 CFR 211.42(c)(10)(iv)). Lastly, cleaning and disinfecting procedures for aseptic areas were incomplete, specifically lacking a reference to certain wipes used for cleaning in the Grade A area of Multi Dose Line (b)(4) (21 CFR 211.42(c)(10)(v)). Allergan's management committed to submitting a written response within 15 business days. For the cleaning procedure observation, an updated SOP was provided during the inspection to incorporate the missing details.

## Related Documents

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- [EIR - 2015-10-08](https://www.keypedia.com/records/eir/allergan-sales-llc/1096c00b-daf1-463c-a301-1855babbb771)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)
- [company_representative](https://www.keypedia.com/people/justin-kuykendall/13444b4f-4892-4b3c-a053-8f19feb412ad)
- [company_representative](https://www.keypedia.com/people/manuel-torrado/19eb3873-3d2e-4cf4-a51a-c0a8aeacf216)
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- [company_representative](https://www.keypedia.com/people/kyle-green/24472ba0-2bbe-4754-932d-9bbe79a21c5f)

Company: https://www.keypedia.com/companies/allergan-sales-llc/dced41da-32c6-41b1-829c-6287550c2c71

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9