Thursday, 8 September 2022 9 .00 - 17.15 h
Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. Some of these reports are available under "Frequently requested or proactively posted compliance records" on the FDA homepage.
On 18 March 2022, an interesting FDA 483 was published. The document dated 10 March 2022 refers to a 10-day inspection from late February to early March 2022 at Cadila Healthcare’s sterile injectable manufacturing site in Jarod, India. The site primarily manufactures injectable drug products for the US market.
The FDA criticises that the stability program is not followed to complete the testing within the period defined in the corresponding SOP. A table with examples is included in the Form 483. From this, it follows that some tests were even delayed by more than 120 days.
It is further stated that for a significant number of batches representative of the commercial products in the market stability testing was delayed as well.
The report also contains two other observations:
The full report is available as a PDF file on the FDA website.