In the letter the FDA said that proposed QA revisions do not address issues that saw SPL take 11-months to investigate reports that its Heparin product was contaminated by oversulfated chondroitin sulfate (OSCS).
“In your response, your firm notes that you have revised your procedure to state, “Any SPL employee will inform QA of a customer complaint.” However, this response does not address the fundamental issues that allowed the delays in communications and investigation to occur.
“Your handling of the heparin contamination complaint suggests the need to evaluate training across all departments about the types of information requiring prompt reporting to the quality unit.”
The FDA also raised concerns about “visual inspection” procedures SPL introduced to makes sure the drug’s raw ingredient, pancreatin, was not contaminated by plastic particles during its removal from storage containers.
“Your response... is deficient in that you do not adequately describe the visual inspection acceptance criteria or provide any data to demonstrate that a visual inspection is an adequate technique to identify plastic shavings of various sizes and colours.”
On a slightly more positive note the FDA said SPL’s updated procedure requiring that contract testing laboratories are qualified before sending samples for release testing was an "adequate" response.
The US agency also welcomed SPL’s introduction of standard operation procedures (SOPs) that make management approval of the audit schedule and vendor qualification status of suppliers a shipment prerequisite.
In response SPL spokeswoman Lori Carlson told in-Pharmatechnologist.com that the company “has already resolved many of the issues addressed in the Warning Letter, including recalling a small amount of product distributed in prior years.
“SPL is committed to ensuring the highest level of quality for its products and is focused on continuous improvement of its quality systems. We intend to respond to the Warning Letter in a timely and comprehensive manner, and we will work closely with FDA as we have in the past."
SPL has until late next week to put together a formal response to the FDA’s letter.