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# Korea’s C&T Dream Co. Gets Form-483
- URL: https://www.fdaweb.com/koreas-c-t-dream-co-gets-form-483/
- Published: 2024-09-23T12:00:00.000Z
- Updated: 2026-09-14T14:42:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157834

A 2023 inspection at C&T Dream Co. (Cheonan, Korea) resulted in a nine-observation [FDA Form-483](https://www.fda.gov/media/182057/download?ref=fdaweb.com) that cites significant GMP deviations. For example, the FDA investigator said the laboratory records are deficient in that they do not include a complete record of all data obtained during testing. The inspection also said control procedures are not established to monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability with in-process material and the drug product. Specifically, the 483 states that the firm has not validated the manufacturing and packaging processes for the OTC drug product “Walgreens Dry Skin Healing Ointment,” and it has not conducted process validation to ensure that the manufacturing and packaging processes can consistently produce a product with known quality, strength, efficacy, and safety. Other violations cited include:

- Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- Equipment for adequate control over air pressure, micro-organisms, dust, humidity and temperature is not provided for the manufacture, processing, packing or holding of a drug product.
- Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
- Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- The containers of components, or drug product containers or closures that are sampled are not opened in a manner to prevent contamination of their contents, contamination of other components, contamination of other drug product containers and contamination of other closures.