17/18 April 2024
An Indian site of the pharmaceutical company Glenmark was inspected by the FDA in November 2017. The FDA now published the form 483* including observations related to bad shipping practice. Data shows that a cream intended for the U.S. market was exposed for more than 30 hours to up to 44.5°C. That alone is bad enough - but the company didn't conduct an investigation "to determine the impact … on the quality and integrity of the product". That is even more interesting as the company had received 21 consumer complaints within two years saying that the cream in question was "watery".
*483 is the number of a form used by an FDA Investigator to document the deficiencies he found during an inspection. It is issued at the end of the inspection and should be answered officially. This response is expected within 15 working days after its issuance. Only then it is guaranteed that the statement will be taken into account in a possible Warning Letter.
Source: FDA 483 Form