One of Glenmark’s Indian plants received more than 20 complaints in the last two years about a cream that buyers said was watery. Warehouse records showed that during storage, the drug was exposed for more than 30 hours to temperatures that ran as high as 112˚F, but the company didn’t investigate to see if that might have been the cause.
That is one of the observations among seven laid out in the inspection of the finished formulations plant in Baddi that the company says accounts for about 10% of its U.S. sales. The FDA last week released a highly redacted version of the Form 483 that came out of the five-day visit in November of the facility which makes creams and ointments as well as tablets.
Temperature excursions were only one of the issues the FDA documented tied to the warehouse at the Baddi plant. Inspectors also noted that warehouse employees had unrestricted access to computers that allowed them to delete records without the QA unit being aware.
In another concern, inspectors found partially destroyed quality records in a shredder that had not been logged for destruction, suggesting a problem the FDA has noted at the plants of other drugmakers.
In a public filing, Glenmark reported the observations and said it was providing a comprehensive response and would reply to the FDA shortly.