# FDA 483 - QuVa Pharma, Inc. - June 16, 2022

Source: https://www.keypedia.com/records/483/quva-pharma-inc/f8ec5435-9552-4eeb-b316-1c4e191e2bb5

> FDA 483 for QuVa Pharma, Inc. on June 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QuVa Pharma, Inc.
- Inspection Date: 2022-06-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: QuVa Pharma, Inc. in Temple, TX, an outsourcing facility, received a Form 483 with four observations related to manufacturing and labeling deficiencies. Issues included unsanitary aseptic processing area floors, use of unvalidated software for BUDs, incomplete master production records, and missing required information on drug product labels. These observations indicate significant concerns regarding facility control, data integrity, and product quality.

## Related Documents

- [483 - 2014-06-20](https://www.keypedia.com/records/483/quva-pharma-inc/47aa03ba-b04e-4926-a794-a4b6ec4de663)
- [EIR - 2022-06-16](https://www.keypedia.com/records/eir/quva-pharma-inc/7a53b3eb-2150-4f37-97c5-34f7cbfe4aa1)
- [483 - 2015-01-23](https://www.keypedia.com/records/483/quva-pharma-inc/8e479d93-55b2-4960-b0a3-8f086815d70d)
- [483 - 2022-06-16](https://www.keypedia.com/records/483/quva-pharma-inc/ab15d9bd-3c3c-4119-b29d-a26e304a890b)
- [483 - 2016-12-08](https://www.keypedia.com/records/483/quva-pharma-inc/e7c58cc6-8304-425b-9536-979bf8fd50f5)

## Related Officers

- [Cameron E. Moore](https://www.keypedia.com/people/cameron-e-moore/5a879539-24b7-4c54-99e4-b8e31f18ec9b)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)

Company: https://www.keypedia.com/companies/quva-pharma-inc/d524a08a-f9a6-49fd-8b83-e0508a9163f9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab