USFDA issued form 483 with 18 observations to Lupin’s biotech facility in Pune, details here

The United States Food & Drug Administration (USFDA) issued a form 483 with 18 observations for Lupin’s biotech manufacturing facility in Pune after concluding a pre-approved inspection at the facility.

The pre-approved inspection was conducted from October 3 to October 14 2022.
CNBC TV18 has accessed the form 483 issued to Lupin’s biotech facility in Pune. The USFDA has issued 18 observations to the facility.
The federal agency has observed that the aseptic monitoring for fill line, the filling and closing machine, is not adequate. The other observations are around lack of adequate product evaluation, remedial action on actionable microbial contamination. USFDA also noted that the Standard Operating Procedures in support of manufacturing are deficient or not followed. The equipment and manufacturing area in the Pune facility is not maintained in a good state of repair.
Here’s the list of observations:

1. Aseptic monitoring for fill line, filling and closing machine not adequate.
2. Did not make adequate product evaluation, remedial action on actionable microbial contamination.
3. Aseptic processing areas are deficient.
4. Protective apparel not worn as necessary to protect drug product from contamination.
5. Growth promotion test of swabs does not reflect routine incubation requirements.
6. A building and raw material in support of drug substance intermediate, manufacture not adequately controlled.
7. Qualified state of a manufacturing utility system is not maintained.
8. Qualification of a facility system for drug product manufacturing is deficient.
9. Training to perform assigned function is deficient.
10. Procedures for decontamination of materials and components not sufficient.
11. Specific identification tests are not conducted on components.
12. Examination and testing of samples did not assure the drug product etc conformed to specifications.
13. Examination and testing of samples did not assure the drug product etc conformed to specifications.
14. Failure to perform a thorough investigation, record of the conclusions, follow ups.
15. Equipment system cleaning specification was inadequate.
16. Batch production and control records are deficient.
17. Standard Operating Procedures in Support of Manufacturing are deficient or not followed.
18. Equipment and manufacturing area used in drug substance and product manufacturing are not maintained in good state of repair.
    However, the company has said that it does not expect an impact to existing revenues from this facility post the observations.
    Lupin’s Tarapur plant receiving a warning letter last month for an inspection conducted between March and April this year. The unit had received an Official Action Initiated (OAI) status in January 2020, followed by four observations on reinspection in April this year.