# FDA 483 - Atlantic Animal Health, Inc. dba Squire Laboratories - May 03, 2019

Source: https://www.globalkeysolutions.net/records/483/atlantic-animal-health-inc-dba-squire-laboratories/31de6986-25e6-4e25-9ccc-e195e5946904

> FDA 483 for Atlantic Animal Health, Inc. dba Squire Laboratories on May 03, 2019. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlantic Animal Health, Inc. dba Squire Laboratories
- Inspection Date: 2019-05-03
- Product Type: veterinary
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Atlantic Animal Health, Inc. dba Squire Laboratories in Revere, MA, received a Form 483 with two observations related to manufacturing practices for Fura-Zone. The inspection revealed failures in component testing, including a repeat observation, and significant deficiencies in equipment cleaning practices and record-keeping. These issues indicate a lack of control over product quality and potential contamination risks.

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