# FDA WARNING_LETTER - Greer Laboratories Inc - November 15, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/greer-laboratories-inc/87f73de6-60b0-4fdb-a69b-db658f574403

> FDA WARNING_LETTER for Greer Laboratories Inc on November 15, 2013. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Greer Laboratories Inc
- Inspection Date: 2013-11-15
- Office Name: Office of Regulatory Affairs
- Summary: The FDA issued a Warning Letter to Greer Laboratories, Inc. on April 21, 2014, following an inspection from November 5-15, 2013. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) requirements for licensed allergenic extracts, which are biological drug products. These violations contravene Section 501(a)(2)(B) of the FD&C Act, the company's Biologics License Application (BLA) under Section 351(a) of the PHS Act, and 21 CFR Parts 210, 211, and 600-680.

Key violations include:
1.  **Unlicensed Custom Mixtures:** Manufacturing and distributing allergenic "custom mixtures" without obtaining a license, as required by 21 CFR 610.17.
2.  **Inadequate In-Process Controls:** Failing to establish and follow written procedures for in-process controls, such as decanting bulk extract without subsequent testing for uniformity and homogeneity, and without quality control unit review (21 CFR 211.110(a)).
3.  **Insufficient Environmental Monitoring:** Inadequate monitoring of viable organisms in the aseptic filling suite, including insufficient air sampling and lack of settling plates during filling operations (21 CFR 211.42(c)(10)(iv

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [David P. Burney](https://www.globalkeysolutions.net/people/david-p-burney/f3a6590c-0191-4878-86a0-f2a2d3424d14)

Company: https://www.globalkeysolutions.net/companies/greer-laboratories-inc/ec669c41-f522-4cf0-8980-1c02c5520949

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64