# FDA 483 - Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. - August 23, 2019

Source: https://www.keypedia.com/records/483/morgan-gallacher-inc-dba-custom-chemical-formulators-inc/edff82e9-0288-43a7-840e-5a05eaadf638

> FDA 483 for Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. on August 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc.
- Inspection Date: 2019-08-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Morgan Gallacher Inc dba Custom Chemical Formulators Inc, a drug manufacturer in Santa Fe Springs, CA, was cited for significant quality control deficiencies during an FDA inspection. The firm released out-of-specification drug products and utilized inadequate reprocessing procedures for expired materials. Additionally, the inspection revealed a failure to conduct annual product reviews and poor controls over computer systems, compromising data integrity.

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## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.keypedia.com/companies/morgan-gallacher-inc-dba-custom-chemical-formulators-inc/cf116ede-f432-4a50-b2ce-47064c96af2c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6