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# QuVA Pharma Cited on GMPs in Form 483
- URL: https://www.fdaweb.com/quva-pharma-cited-on-gmps-in-form-483/
- Published: 2019-04-15T12:00:00.000Z
- Updated: 2026-09-15T01:20:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143862

FDA has posted a 3/14-completed Form 483 that includes nine observations from an inspection at Temple, TX-based QuVa Pharma. (XXX DELETE XXX)Agency investigators cited the firm for not having adequate written procedures to describe in sufficient detail the receipt, identification, approval, and rejection of components. The form also cited QuVa Pharma for not having established written methods of cleaning or methods of processing to remove pyrogenic properties. Additionally, investigators cited deficient environmental monitoring in aseptic processing areas. To view the Form 483, click [here](https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm635450.pdf?ref=fdaweb.com).