# FDA 483 - Barr Laboratories Inc. - April 14, 2017

Source: https://www.globalkeysolutions.net/records/483/barr-laboratories-inc/a39966de-d61c-4a1e-a44c-9738f3878b6f

> FDA 483 for Barr Laboratories Inc. on April 14, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Barr Laboratories Inc.
- Inspection Date: 2017-04-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Barr Laboratories, Inc. in Forest, VA, revealed significant deficiencies across multiple systems. Observations included inadequate equipment design and qualification, a lack of environmental monitoring to prevent microbial contamination, and failures in batch production recordkeeping. The findings indicate a moderate level of non-compliance with good manufacturing practices.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/barr-laboratories-inc/e293af5c-de58-4574-b3d6-25bc0cd3594d)
- [483 - 2022-11-04](https://www.globalkeysolutions.net/records/483/barr-laboratories-inc/344e391b-330e-4570-b63c-f374431099ff)
- [483 - 2025-05-09](https://www.globalkeysolutions.net/records/483/barr-laboratories-inc/b793dc2e-2608-4d3a-83f0-ffc8d10b5f86)
- [483 - 2025-05-09](https://www.globalkeysolutions.net/records/483/barr-laboratories-inc/c0dc6647-bb49-4ee8-83b6-95a22557254b)

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.globalkeysolutions.net/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)
- [investigator](https://www.globalkeysolutions.net/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

Company: https://www.globalkeysolutions.net/companies/barr-laboratories-inc/c462b6c3-5357-4446-9aad-53dd2b49b1ce

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e