# FDA 483 - Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. - October 26, 2023

Source: https://www.globalkeysolutions.net/records/483/morgan-gallacher-inc-dba-custom-chemical-formulators-inc/b437ace3-29d5-48b1-b403-447d0f1770f0

> FDA 483 for Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. on October 26, 2023. 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: 2023-10-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 report details significant Good Manufacturing Practice deficiencies at Morgan Gallacher, Inc DBA Custom Chemical Formulators Inc. The firm was cited for a range of issues, including a deficient quality control unit, lack of process validation, inadequate equipment cleaning and qualification, and insufficient testing and record-keeping for drug components and finished products. These observations indicate a systemic lack of control over critical manufacturing processes and quality assurance.

## Related Documents

- [483 - 2019-08-23](https://www.globalkeysolutions.net/records/483/morgan-gallacher-inc-dba-custom-chemical-formulators-inc/edff82e9-0288-43a7-840e-5a05eaadf638)
- [483 - 2024-10-30](https://www.globalkeysolutions.net/records/483/morgan-gallacher-inc-dba-custom-chemical-formulators-inc/5c9effbf-89c7-4a0a-865c-82cd8d650941)

## Related Officers

- [Statistical Science Director](https://www.globalkeysolutions.net/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

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

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