# FDA WARNING_LETTER - AllerQuest LLC - March 01, 2019

Source: https://www.keypedia.com/records/warning_letter/allerquest-llc/8f69bb1d-3ef0-4d9f-9a2b-880a40460d0f

> FDA WARNING_LETTER for AllerQuest LLC on March 01, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: AllerQuest LLC
- Inspection Date: 2019-03-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to AllerQuest LLC following an inspection from January 31 to March 1, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include:
1.  **Inadequate Facility Design and Control (21 CFR 211.42(c)):** The sterile injectable drug manufacturing facility's ISO 5 critical area directly interfaces with double doors having substantial gaps, posing a contamination risk from unclassified air. The aseptic processing line design is inadequate, with limited protection and high exposure to contamination. The firm's response regarding third-party consultants and sterility testing was deemed insufficient.
2.  **Failure to Control Aseptic Processing Areas (21 CFR 211.42(c)(10)):** The firm failed to adequately address environmental control departures, including Bacillus sp. in the ISO 5 area, and used non-sporicidal agents for disinfection. Environmental and personnel monitoring programs were inadequate, with uninvestigated excursions and incorrect action limits for fingertip sampling. The firm lacked a continuous monitoring system for temperature, humidity, and pressure, leading to uninvestigated excursions.
3.  **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate recurrent foreign particulate matter contamination in sterile injectable drug products, despite thousands of ampules failing specifications and

## Related Officers

- [Deputy District Director](https://www.keypedia.com/people/craig-w-swanson/7fddeef9-fb53-48ba-afc2-80e15d7f777f)
- [James M. Mason](https://www.keypedia.com/people/james-m-mason/a9f601a9-5d81-4386-90dc-80466edb5880)

Company: https://www.keypedia.com/companies/allerquest-llc/48c73c8a-6e36-4054-a572-2c338301b640

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c