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# Multiple CGMP Violations at Colorful Products
- URL: https://www.fdaweb.com/multiple-cgmp-violations-at-colorful-products/
- Published: 2022-05-17T12:00:00.000Z
- Updated: 2026-09-14T17:45:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151825

An 11/8-11/17/21 FDA inspection at the Colorful Products drug manufacturing facility, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter topical drug products and hand sanitizers. A 5/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colorful-products-corporation-624415-05102022?ref=fdaweb.com) says specific violations were: 

- failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to clean, maintain and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, and failing to establish written procedures for cleaning and maintaining equipment; and
- failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records.

The letter says FDA strongly recommends that Colorful Products engage a qualified consultant to assist it in meeting CGMP requirements. It also states FDA has not received a response from the company to the inspection observations shown on the FDA-483 issued following the inspection.

Colorful Products was told to address any violations promptly and to respond with a list of specific steps it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.