Colonial Dames Company, Ltd

Warning LetterOpen

Mr. Kort V. Pearson Chief Executive Officer Colonial Dames Company, Ltd 6820 Watcher Street Commerce , CA 90040 United States kort@colonialdames.comFEI 2011035Issued Dec 5, 2023Division of Pharmaceutical Quality Operations IV

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2011035.

Violations10

Issue DateDec 5, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Colonial Dames Company, Ltd
Location: Mr. Kort V. Pearson Chief Executive Officer Colonial Dames Company, Ltd 6820 Watcher Street Commerce , CA 90040 United States kort@colonialdames.com
FEI Number: 2011035
Country: United States
Issue Date: December 05, 2023
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Colonial Dames Company, Ltd received a warning for manufacturing adulterated drug products that failed to comply with Current Good Manufacturing Practice (CGMP) regulations, with specific violations involving two oxygenetix® products (a foundation and acne control product) that were unapproved new drugs introduced into interstate commerce. The company's manufacturing methods, facilities, and controls did not meet CGMP standards outlined in 21 CFR parts 210 and 211, and the products were also misbranded and not properly listed with the FDA as required. Additionally, the company failed to fulfill its drug listing obligations under FDA regulations, which constitutes a prohibited act.

Colonial Dames Company, Ltd FDA Warning Letter, December 5, 2023