FDA issues warning letters to several companies

In the first half of February, the FDA posted to its website several warning letters to companies and facilities for violations of cGMP regulations. The agency’s Center for Drug Evaluation and Research and Division of Pharmaceutical Quality Operations divisions sent warning letters to two hand sanitizer companies, a Turkish drug manufacturer, a Palm Beach Fertility Center and a dietary supplement facility. The FDA says that if these companies don’t follow the regulations specified in the warning letters, they could face regulatory or legal action.

Warning letter to Clean Cosmetics over cGMP violations

Clean Cosmetics received a warning letter from the FDA for not complying with cGMP regulations for hand sanitizer. The FDA found that they didn’t test the components of their drug products, had inadequate laboratory controls and didn’t comply with quality controls for drug products. The FDA says that the company might face legal action if they don’t address these problems. Clean Cosmetics informed the FDA that it would cease the production of drugs.

FDA also chides Salon Technologies over hand sanitizer issues

The Orlando-based manufacturer Salon Technologies International is also under FDA scrutiny for hand sanitizer products. While the company claims its products are FDA-registered, recent FDA lab tests revealed unacceptable levels of impurities and a failure to comply with Current Good Manufacturing Practice (cGMP) requirements. The FDA has demanded a thorough investigation and asked the company to provide detailed records of all batches distributed in the U.S. Additionally, the agency has requested that the company provide a list of raw materials used in manufacturing.

FDA demands comprehensive remediation plan for Turkish drug manufacturer

FDA issued a warning letter to Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, a drug manufacturing facility in Istanbul, for significant cGMP violations for finished pharmaceuticals. The agency also said the firm needed an adequate testing program to evaluate the stability characteristics of drug products. The FDA has asked for a comprehensive remediation plan and a cGMP consultant to comply with regulatory requirements. If the facility doesn’t fix the violations within 15 working days, the FDA may withhold approval of new applications or supplements listing the facility as a drug manufacturer and continue to refuse admission of articles manufactured at the facility into the U.S.

Warning letter for Palm Beach Fertility Center in Florida

The FDA inspected Dr. Mark S. Denker Palm Beach Fertility Center in Florida and found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. The problems the agency reported include not verifying if the donors have any risk factors for infectious diseases, not keeping records of the donors’ medical records for infectious diseases and not communicating positive cytomegalovirus (CMV) test results to physicians. The agency also alleges that the facility didn’t follow the regulations for labeling their human cells, tissues, and cellular and tissue-based products (HCT/Ps). It also took issue with the facility’s response to an earlier FDA inspection.

The FDA provided specific concerns and comments on the establishment’s responses to the observations. The list included ensuring the facility uses a revised screening questionnaire and fixing deficiencies in donor eligibility records. The establishment also must improve its procedures for releasing HCT/Ps from donors with reactive specimen tests for CMV. The FDA also stated that the facility must require donors with positive test results for a relevant infectious disease to be determined ineligible and adequately label their products.

FDA finds serious violations at dietary supplement facility in Oklahoma City

The FDA has identified serious violations of the FD&C Act and applicable regulations at a facility owned by Raymundo Osuna in Oklahoma City. The facility manufactures dietary supplements. The FDA has given the company 15 days to address the violations, or legal action may result, including seizure and injunction. The violations involve failing to manufacture products in line with cGMP regulations and meet labeling requirements for dietary supplements.

The agency warns company over hand sanitizer violation

FDA sent a warning letter to The Body Bean LLC over the failure to register their establishment and list their hand sanitizer with the FDA. The company has requested the company to explain and document specific steps to address the violation within fifteen working days. Failure to address the issue may result in legal action, including seizure and injunction.