# FDA 483 - Allay Pharmaceuticals, LLC - May 15, 2020

Source: https://www.keypedia.com/records/483/allay-pharmaceuticals-llc/d33a2da0-ba21-4d1e-90a5-ffa16176a92c

> FDA 483 for Allay Pharmaceuticals, LLC on May 15, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allay Pharmaceuticals, LLC
- Inspection Date: 2020-05-15
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Alley Pharmaceuticals, LLC received a Form 483 citing significant deficiencies across its quality system. Observations included failures in quality unit responsibilities, complaint handling, process validation, stability testing, laboratory controls, data integrity, raw material testing, investigation of discrepancies, and employee training. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.

## Related Documents

- [WARNING_LETTER - 2020-05-15](https://www.keypedia.com/records/warning_letter/allay-pharmaceuticals-llc/9d8f296d-0640-4430-8719-aceea19b0656)
- [483 - 2021-11-15](https://www.keypedia.com/records/483/allay-pharmaceuticals-llc/94cd1a5a-c25d-4a99-979f-66078c50817b)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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

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