# FDA 483 - STAQ Pharma, Inc. - September 29, 2021

Source: https://www.keypedia.com/records/483/staq-pharma-inc/2fa9a4f6-4415-46a3-8529-668df11e2bb9

> FDA 483 for STAQ Pharma, Inc. on September 29, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: STAQ Pharma, Inc.
- Inspection Date: 2021-09-29
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: On September 29, 2021, the FDA issued a Form 483 to STAQ Pharma, Inc., an outsourcing facility located at 14135 E 42nd Avenue, Suite 50, Denver, CO 80239-5214, following an inspection conducted from September 20-24 and 27-29, 2021. The inspection identified three observations.

Observation 1 noted that procedures to prevent microbiological contamination of sterile drug products lacked adequate aseptic process validation. Specifically, the ISO 5 Laminar Flow Hood (LFH) and ISO 7 Room were not recertified after the LFH was moved on September 17, 2020, yet the firm continued producing aseptically filled syringes. Additionally, nonviable and viable air samplers inside the ISO 5 LFH were not operational during a dynamic smoke study on September 17, 2020.

Observation 2 indicated deficiencies in the environmental monitoring system for aseptic processing areas. Environmental monitoring was absent for ancillary equipment within the ISO 5 LFH, including non-viable and viable hoses, a power cord from a pump to an electrical outlet, protruding screw caps, an IV hanging bar and hooks, and an L-shaped bar supporting the fill bag.

Observation 3 stated that the outsourcing facility failed to submit required product reports to the FDA for compounded

## Related Documents

- [483 - 2020-09-03](https://www.keypedia.com/records/483/staq-pharma-inc/37e4548a-98f4-4db1-a8e0-28ad1fa85d44)
- [483 - 2020-09-03](https://www.keypedia.com/records/483/staq-pharma-inc/9cd68478-5d14-4932-af36-6fef02a88e3f)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Drug Enforcement Administration](https://www.keypedia.com/people/john-a-gonzalez/51074472-cb23-4b72-8ca7-2d973670063e)

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

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