Maryland Manufacturer Receives FDA Form 483 Over Sanitation
A Maryland manufacturer received a three-observation Form 483 after an inspection revealed inadequate sterility controls.
An inspection of Pharmaceutics International’s facility in Huntsville uncovered a slew of deficiencies tied to the sterility assurance of its cancer, osteoporosis and nausea products.
The 483 details instances when operators neglected to follow proper protocol, placing products at risk for contamination.
One operator, for example, reached over uncovered vials. Another operator sanitized items in the wrong order — cleaning first the exterior, then the interior. A third operator touched the soiled part of a wipe, while using its other side to clean.
FDA inspectors noted that the company lacked certain procedures to prevent the microbiological contamination of drug products. For instance, the manufacturer did not establish any extractable or leachable studies to identify, quantify and assess compounds transferred from a filter to the process stream.
The agency pointed out that the company also lacked tests to evaluate the integrity of its containers and closures.
The May 2015 inspection also concluded that the company neglected to take corrective measures to address discrepancies, such as bacteria reported from a personnel monitoring sample.
In June, the UK’s Medicines and Healthcare products Regulatory Agency ordered the manufacturer to recall drug batches, suspend clinical trials and cease distribution after its inspection uncovered critical GMP violations.
The company did not respond to a request for comment.
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