FDA Form 483: Sampling Obviously Documented Incorrectly

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 August 2022, a new FDA Form 483 was published. The document dated 12 August 2022 goes back to an inspection from 03 to 12 August 2022 at India-based manufacturer Sun Pharmaceutical Industries Limited. In total, the document contains six observations related to various GMP violations found at the facility in Mohali.

Sampling not Documented at the Time of Performance

GMP relevant activities were not documented at the time of performance. This concerns sampling in particular.

The FDA investigator writes: "Building access records showed an employee responsible for collecting samples did not enter the buildings where the samples were documented to have been collected or that the employee was in a different building at the time the sample was documented to have been collected."

The FDA Form 483 lists a whole series of specific cases, such as the following:

  • "On January 29, 2021, [a] sample [...] was documented to have been collected at 12:37 inside the manufacturing area in the production block. Badge access records show the employee documented to have collected the sample entering the quality dining room at 12:35 in the quality block, a different building."
  • "The sampling records show the employee collecting a sample [...] at 13:02 on the service floor of the production block. Badge access records show the employee leaving a changing room in the quality block, a different building, at 13:03."

Besides sampling, the document also lists other examples where entries were not made into GMP records contemporaneously.

Further Observation

The other five observations are as follows:

  • Sun Pharmaceutical Industries Limited failed to thoroughly review unexplained discrepancies.
  • Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
  • Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
  • Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
  • Written procedures are not followed for the testing of components.

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

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