# FDA 483 - Allay Pharmaceuticals, LLC - November 15, 2021

Source: https://www.globalkeysolutions.net/records/483/allay-pharmaceuticals-llc/94cd1a5a-c25d-4a99-979f-66078c50817b

> FDA 483 for Allay Pharmaceuticals, LLC on November 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allay Pharmaceuticals, LLC
- Inspection Date: 2021-11-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Allay Pharmaceuticals, LLC in Miami Gardens, FL, a drug manufacturer, revealed significant deficiencies in their quality control unit procedures and master production records. The firm's written procedures for complaint handling, adverse event reporting, and raw material sampling were found to be incomplete, contain inapplicable requirements, or not be fully followed. Additionally, master batch records for NP Thyroid tablets lacked complete manufacturing and sampling instructions.

## Related Documents

- [483 - 2020-05-15](https://www.globalkeysolutions.net/records/483/allay-pharmaceuticals-llc/d33a2da0-ba21-4d1e-90a5-ffa16176a92c)
- [WARNING_LETTER - 2020-05-15](https://www.globalkeysolutions.net/records/warning_letter/allay-pharmaceuticals-llc/9d8f296d-0640-4430-8719-aceea19b0656)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)
- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.globalkeysolutions.net/companies/allay-pharmaceuticals-llc/20d57aab-16cc-49b7-aa6a-1e9942240fa8

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6