Roof Leaks Result in 483 for Luitpold Pharma
Luitpold Pharmaceuticals was chided by the FDA for failing to properly investigate how severe roof leaks in 2013 and 2014 affected production.
The agency inspected Luitpold’s Shirley, N.Y., facility back in October and found that the company’s investigations into recurring mold in aseptic processing areas and support rooms didn’t take into account several roof leaks that occurred during high rainfall periods.
“In addition, the firm was unable to determine how long roof damage in the form of cracks of varying sizes had been in existence prior to the above referenced leakages,” said the five-observation form.
Luitpold also needed to consider whether leaks occurred during low rainfall periods, the agency said.
The FDA further rapped the drugmaker for not closing investigations into batch problems in a timely manner. Investigators reviewed the company’s database and found a number of investigations still open with no documented rationale.
Luitpold told the FDA that batches associated with open investigations were not released. However, the agency was concerned that Luitpold didn’t look into how the problem may affect other batches and production lines.
Luitpold did not return a request for comment as of press time.
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