FDA Form 483 lists 10 Observations made during an Inspection of an Indian Drug Manufacturer

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. The FDA regularly publishes some of these reports under "Frequently requested or proactively posted compliance records" on the FDA homepage.

The authority has issued a new Form 483 following an inspection of Alkem Laboratories Limited, a drug manufacturer located in Baddi, Himachal Pradesh, India. The document was published on 09 April 2024 and goes back to an inspection from 19 to 27 March 2024.

The FDA observed several deficiencies during the inspection, particularly related to the quality system. The 17-pages report lists a total of 10 observations.

One significant observation (Observation 1) relates to the failure to thoroughly review unexplained discrepancies and failures of batches to meet specifications. Specifically, there was a failure in the preventive maintenance of a Perkin Elmer UV Spectrophotometer, resulting in its retirement without conducting an investigation or impact assessment on previously generated test results. Batches tested with this malfunctioning instrument were released into the US market, raising concerns about the accuracy and reliability of the test results.

The other observations include the following aspects:

• No shipping studies of finished products shipped to US markets were performed.
• Change Controls are not managed and closed within the specified timeframe.
• The company failed to adequately perform and assess the GxP impact for computerized system/software.
• Appropriate controls governing computer acquired data have not been established.
• The firm failed to handle and store drug product containers at all times in a manner to prevent contamination.
• Analytical results were not documented according to the SOP.
• No annual visual examination of reserve samples was performed.

The full report, which includes more examples and further information, is available as a PDF file on the FDA website.