FDAnews Drug Daily Bulletin

GMP Violations Earn U.S. Drug Manufacturer FDA Warning Letter

Dec. 20, 2016

The FDA issued a four-observation warning letter to Pocono Coated Products for violating GMP standards.

An agency inspection in October revealed the company released drug products to customers without conducting final tests to determine if products conformed to specifications.

The FDA collected samples of finished drug products from the company and found that its drug was sub-potent and contained product labeling that was inconsistent with analysis results. Given these findings, all lots of the drug product were recalled.

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