FDA Form 483 due to Delayed Stability Testing at a Sterile Injectable Manufacturing Site

Recommendation

5-8 December 2023

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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.

Written Stability Testing Program Not Followed

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.

Further Observations

The report also contains two other observations:

• The Quality Unit (QU) failed to complete the annual product quality reviews (APQRs) for seven different products within the due period.
• Buildings used in the manufacturing processing are not maintained in a good state of repair. This concerns, in particular, a compounding room used in the manufacturing of sterile injectable drugs for the US market.

The full report is available as a PDF file on the FDA website.