Contamination Issues, Quality Lapses Gets Natco Form 483

The FDA smacked Natco Pharma for contamination problems and quality control lapses following an inspection of its Rangareddy, Telangana, India facility from Oct. 9 to 18.

In the 27-page, eight-observation Form 483, the FDA investigators said the drugmaker failed to ensure equipment and utensils were cleaned and maintained at appropriate intervals “to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.” 

For example, the agency discovered a “thick build-up” on equipment labeled as cleaned, and test data revealed the presence of unspecified substances “up to about 800 times the acceptance limit” indicating a potential risk for cross-contamination of drug product. 

Read the FDA Form 483 here.

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