Global Biotech Fails GMPs After Product Seizure

STONEHAM, Mass.Just months after U.S. Marshals seized products from Global Biotechnologies Inc. for illegal marketing claims, FDA found the company's production facility did not meet cGMPs (current good manufacturing practices).

FDA inspected the Portland, ME, facility from Jan. 25, 2012, to March 16, 2012, and reported the GMP violations cause the company's Glucanol and Lactopril dietary supplement products to be adulterated per the Federal Food, Drug, and Cosmetic Act.

During the inspection, FDA found Global Biotechnologies'  did not establish in-process specifications in master manufacturing records (MMRs). Specifically, FDA said the company did not have specs for  capsule weight for its Lactopril product.  The company also didn't have an MMR for its Glucanol supplement.

FDA found the company did not have raw material specs (RMS), and the agency said the company's batch production records (BPRs) for Lactopril was incomplete because they didn't include required information , such as the date and time of equipment maintenance , the weight or measure of each ingredient and a statement of yield.

Global Biotechnologies'  did not monitor temperature and humidity frequently enough to determine if products' identity, purity, strength and composition could be affected. The company also did not have written procedures for product complaints.

'Inadequate' Response

Like some other companies that have received form 483s from FDA outlining the agency's concerns following an inspection, FDA found Global Biotechnologies' response to be inadequate because it lacked "sufficient corrective action."

In its March 30, 2012, response, Global Biotechnologies said addressed these issues, but FDA said it wanted proof. FDA said it wanted to see the updated MMRs, RMS and BPRs. The company didn't provide these, so FDA sent this warning letter.

INSIDER's Take

When FDA finds violations during a GMP inspection, it gives the company a 483 Form, which the company should respond to. If FDA finds that response adequate, the agency will not send a warning letter. However, if FDA finds the response lacking, the supplement company will be hearing from the agency. Here, FDA tells industry that it wants to see proof that violations were corrected in the form of MMRs, BPRs and spec sheets. If a company gets a 483 Form, it should be ready with copies of these important documents to send to FDA.

This letter also once again proves that when a company has had one run in with FDA, the agency keeps watch. If a company has violated lawsGMP-, claim- or otherwiseit need to be hyper vigilant, because FDA will most likely be back.

Brand owners can increase their changes of passing GMP inspections by attending GMP Training Session at SupplySide West, Nov. 6 and 7, 2012, in Las Vegas.