# FDA 483 - Greer Laboratories, Inc. - September 11, 2019

Source: https://www.globalkeysolutions.net/records/483/greer-laboratories-inc/9b4cbc1e-1401-4e3a-aed1-12409d04b147

> FDA 483 for Greer Laboratories, Inc. on September 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greer Laboratories, Inc.
- Inspection Date: 2019-09-11
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Greer Laboratories Inc, an allergenics manufacturer in Lenoir, NC, revealed significant deficiencies in quality control and manufacturing practices. Observations included the release of rejected in-process materials, foreign material contamination in aseptic processing areas, and the use of unreleased bulk extracts. Additionally, the firm's corrective action review process was found to be inadequate, leading to product recalls and rejected lots.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/greer-laboratories-inc/9e93bfa2-3578-44bb-93cd-fa80496d73a5

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7