Regulatory Focus™ > News Articles > 2019 > 2 > FDA Warns Spanish Firm Over GMP, Data Integrity Issues

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Posted 27 February 2019 | By Michael Mezher 

FDA Warns Spanish Firm Over GMP, Data Integrity Issues

2761 The US Food and Drug Administration (FDA) this month warned Spanish over-the-counter (OTC) drugmaker Proandre SL over good manufacturing practice (GMP) and data integrity issues that landed the firm on import alert in November.
FDA inspected Proandre’s Barcelona facility over the course of four days last June, finding that its OTC Proandre antibacterial soap and hand sanitizer liquid are adulterated and misbranded. Two other products are cited in the warning letter as well, but their names have been redacted.
The warning letter comes after FDA’s recent crackdown on antibacterial soaps that saw the agency ban 19 ingredients from use in consumer antibacterial washes over concerns that the ingredients may not effectively eliminate bacteria.
Warning Letter
In the warning letter, FDA cites Proandre for failing to adequately test its products and for poor data integrity practices.
FDA says the company released batches of three of its products, including Proandre antibacterial soap liquid, without conducting identity and strength testing. The agency notes that the firm admitted to only conducting microbiological testing and tests to measure specific gravity, pH and refraction value.
FDA also says that Proandre failed to follow its own stability testing procedures. In one instance, FDA says the company ran its three-month stability test for a lot of one of its products on the day it was packaged, then ran the six-month stability test nine months later.
“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,” FDA writes, recommending that the company hire a consultant to assist with overhauling its data integrity practices.
During the inspection, FDA says it found batch records that had information covered up by white-out, “unintelligible data” and information that was missing altogether. The agency notes that some records were “over written and crossed out” without explanation.
Other records for laboratory test results for viscosity, density, appearance and odor were found to be lacking initials or signatures indicating that the records were reviewed.
FDA also says that Proandre’s antibacterial soaps are misbranded for failing to meet labeling requirements.
Specifically, FDA says the antibacterial soaps violated labeling requirements by including information in both Spanish and English without bearing a Drug Facts section in Spanish. Under the Food, Drug & Cosmetic Act, drug products with “any representation in a foreign language” must include all required labeling information in that language.
FDA also says the products are misbranded as they do not include a domestic address or telephone number for reporting adverse events.
Warning Letter


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