# FDA 483 - STAQ Pharma, Inc. - September 03, 2020

Source: https://www.globalkeysolutions.net/records/483/staq-pharma-inc/37e4548a-98f4-4db1-a8e0-28ad1fa85d44

> FDA 483 for STAQ Pharma, Inc. on September 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: STAQ Pharma, Inc.
- Inspection Date: 2020-09-03
- Product Type: drugs
- Office Name: Denver District Office
- Summary: STAQ Pharma, Inc. in Denver, CO, an outsourcing facility, received an FDA Form 483 citing multiple deficiencies. These included inadequate investigations into product discrepancies, insufficient aseptic process validation, and poor environmental monitoring. Additionally, issues with cleaning procedures and deficient drug product labeling were noted.

## Related Documents

- [483 - 2020-09-03](https://www.globalkeysolutions.net/records/483/staq-pharma-inc/9cd68478-5d14-4932-af36-6fef02a88e3f)
- [483 - 2021-09-29](https://www.globalkeysolutions.net/records/483/staq-pharma-inc/2fa9a4f6-4415-46a3-8529-668df11e2bb9)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/staq-pharma-inc/5523c958-fa2f-4739-a81d-699298538a9f

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face