Warning Letter issued to US Company because of Lack of Product and Process Control

 On August 5, the FDA issued a warning letter to LS Promotions Inc. in Hicksville, addressing several CGMP violations. The letter, following the review of the company's response to a 483 letter, outlines issues in:

Laboratory Testing: The company failed to perform required tests on each batch of drug products, including identity and strength verification and microbiological testing for items like SPF 15 lip balm and SPF 30 sunscreen.

Stability: LS Promotions lacked a proper stability testing program to support product shelf life and storage conditions. No stability studies were detailed in their response.

Product and Process Control: Inadequate procedures and validation for manufacturing processes and equipment cleaning were noted. The FDA requires a detailed process validation program and improved cleaning procedures.

Quality Unit Responsibility: The Quality Unit did not ensure CGMP compliance. The FDA expects a thorough remediation plan for QU responsibilities and oversight.

More details are available in the FDA's Warning Letter on their website.