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# CGMP, Registration Violations at Former Deb USA
- URL: https://www.fdaweb.com/cgmp-registration-violations-at-former-deb-usa/
- Published: 2019-09-17T12:00:00.000Z
- Updated: 2026-09-15T01:50:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145019

A 10/22-10/30/18 FDA inspection at SC Johnson Professional (formerly Deb USA), Stanley, NC, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and requirements for registration and listing of drug products. A just-released 6/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/deb-usa-inc-570944-06112019?ref=fdaweb.com) says specific CGMP violations were: 

- failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures applicable to the quality control unit;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to establish and follow required laboratory control mechanisms;
- failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards; and
- failing to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. SC Johnson was told to provide **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and **(3)** a management strategy for the firm that includes details of a global corrective and preventive action plan.

Based on the nature of the violations identified at the firm, FDA recommends that it engage a qualified consultant to assist it in meeting CGMP requirements.

The letter also says the firm’s listing information for Kindest Kare Antimicrobial Foam Handwash includes inaccurate information, in that the active ingredients do not match between the labeling and the electronic listing file. In addition, it says, the firm’s Web site says the handwash has been discontinued but the drug listing file has been certified as being current for calendar year 2019.

SC Johnson was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.