| Category |
Press Release |
| Publish Date |
10/27/2020 |
| Author |
Paul Cochrane |
| Title |
Face Powders Placed on FDA Import Alert List Due to Microbial Contamination Concerns |
| Introduction |
MPL Laboratories provides sterility and other microbial testing services for cosmetics, personal care products, pharmaceuticals and consumer goods in an FDA registered, cGMP and ISO 17025 compliant testing facility. |
Sparta, NJ, October 27th, 2020
Earlier this year, the U.S. Food & Drug Administration (FDA) listed a cosmetics company out of China on the agency’s Detention Without Physical Examination (DWPE) import alert list due to microbial contamination concerns.
An import alert informs the FDA's field staff and public that the agency has enough evidence to allow for DWPE of products that appear to be in violation of the FDA's laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information. Before importing into the United States, importers should know if their products are subject to DWPE, it allows the agency to detain a product without physically examining it at the time of entry.
The DWPE in this case is for face powders that could have microbial contamination due to Bacillus species, including B. cereus. Bacillus species are widely distributed throughout the environment and the FDA has reported that B. cereus contaminated eye-area products may cause users to develop bacterial conjunctivitis, keratitis and periorbital cellulitis. In particular, this pathogen can cause a rapidly progressive endophthalmitis (i.e., inflammation of the intraocular cavities or the aqueous and/or vitreous humor of the eye) that is resistant to treatment. Significant loss of vision, and often loss of the eye itself, can occur within 24 to 48 hours after exposure to B cereus.
The spores of Bacillus are resistant to disinfectants, sterilization, radiation, desiccation and efforts to destroy them through high or low temperatures. This makes them a significant contamination challenge for manufacturers of cosmetics, medical supplies, consumer goods and even food products.
The scientists at MPL Laboratories are dedicated to helping manufacturers, importers, regulatory agencies and public health officials identify Bacillus species and other microbial contaminants in products. MPL operates an FDA and DEA registered testing facility that offers cGMP and ISO 17025 compliant microbiology testing services.
To learn more about this or other testing services provided by MPL Laboratories, please visit www.MPLLaboratories.com, call (800) 548-1874 or email info@MPLLaboratories.com.
About MPL Laboratories
MPL Laboratories (formerly Marypaul Laboratories) was founded in 1985 as a full-service microbiology laboratory. It is ISO/IEC 17025 accredited by PJLA, FDA and DEA registered, and NJDEP certified. MPL’s staff includes M.S. and B.S. degreed microbiologists and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, cosmetic, personal care and food industries. MPL aims to provide its clients with high quality, reliable test data in a timely manner. The laboratory is part of the EMSL Analytical, Inc. network of laboratories across the United States and Canada. |
