> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Multiple Violations in Kim Chemicals Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-kim-chemicals-inspection/
- Published: 2017-10-31T12:00:00.000Z
- Updated: 2026-09-14T22:59:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140007

A 6/5-6/9 FDA inspection at India’s Kim Chemicals Private Ltd. found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/16 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581853.htm?ref=fdaweb.com). The inspection also determined that Kim Chemicals manufactures unapproved new drug and misbranded drug products, the letter says. Specifically, Sofskin Vaporizing Chest Rub and Sofskin Pure Petroleum Jelly are unapproved new drugs and also are misbranded.

Specific CGMP violations noted in the letter were: 

- failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release;
- failing to establish an adequate quality control unit and procedures applicable to the quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products; and
- failing to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. “We strongly recommend that you retain a qualified consultant to assist in your remediation.”

Kim was told to submit a comprehensive investigation into the extent of inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of the drugs; and a management strategy for the firm that includes details of its global corrective action and preventive action plan.

The letter describes the ways in which the firm’s products fail to meet formulation and labeling requirements described in the applicable final monographs. It also says that the company’s Sofskin Vaporizing Chest Rub is not the subject of an FDA-approved application and thus its marketing is a violation. In addition, the product’s label fails to disclose a domestic address or telephone number through which the responsible person may receive a report of a serious adverse event with the drug.

The Sofskin Pure Petroleum Jelly fails to meet the requirements in the skin protectant final monograph, FDA says, and is not the subject of an FDA-approved application. It is misbranded because the label doesn’t bear a complete statement of identity.

FDA placed the firm on import alert on 8/21\. The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.