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Exclusive: We Reveal The Observations Made By US FDA’s Inspection Of Sun Pharma’s Halol Facility

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True to our promise of keeping a tab on the US FDAs inspection of Sun Pharma’s Halol facility, we are happy to get our hands on the Form 483 issued for the re-inspection conducted against the warning letter of December, 2015 and the initial inspection of September, 2014.
This is not a recommendation to buy or sell the stock. Analyst and family do own some of the positions listed here. Please assume we are biased.


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Observation 1:

Field Alert Reports were not submitted within 3 working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
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Our Understanding: We reported on 27-Jul about Sun Pharmaceutical Industries recalls 16,085 bottles of antidepressant tablets. Sun has recalled 36,622 bottles of the buPROPion Hydrochloride tablets since then.
The observation that the FDA inspection have made is for the same product. Basically the Sun Pharma team delayed filing the reports of the investigations as well as did not test sufficient quantity of the control samples to perform L2 and L3 testing. No follow up Field Alert Report, Insufficient Testing, Delayed identification of failures, Absence of immediate corrective action, absence of communication to the FDA over failures was noted.
Field Alert Reports is submitted to the FDA if a manufacturer finds any significant problems with an approved drug.

Observation 2:

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Our Understanding: FDA recommends Dissolution Analysis to be performed for the recalled products. However, even after the analysis Sun Pharma failed to revise the expiration of all live market batches – a sample test on which was conducted on 26-May-15. Also a communication to the FDA was not made to date.
Dissolution Testing is used for the approval of safe and effective generic drug products and is routinely used for stability and quality control purposes for both oral and non-oral dosage forms.

Observation 3:

Testing programs are not adequately designed to access the stability characteristics of drug products. Specifically, test schedules established by stability protocols are not adhered to so as to characterize the degradation of products over their actual shelf lives.
Our Understanding: This observation was in relation to the same product which was highlighted in Observation 1.

Observation 4:

Establishment of test procedures including any changes thereto are not adequately reviewed and approved by the quality control unit.
Our Understanding: Again related to Observation 1, root cause of the failures were not identified during the lab investigation. While this was communicated to the production team, they as well couldn’t identify the root cause of the failure in production activities.
The current test procedures is silent on the requirement for de-aeration of dissolution medium. The CDER Reviewing Division or Center for Drug Evaluation and Research were not informed as to the change in method of dissolution testing.

Observation 5:

Accuracy of the tests not established.
Our Understanding: This has to be read in continuation to Observation 4. No re-validation was performed to assess the effect of the change on method accuracy prior to the implementation for testing the commercial and stability batches.

Observation 6:

Scientifically sound and appropriate laboratory control mechanisms are not established to assure that components, drug product containers, closures, in-process materials, or drug products conform to appropriate standards of identity, strength, quality and purity.
Our Understanding: For sample population suspected for turbidity (cloudiness or haziness of a fluid caused by large numbers of individual particles). The samples were tested by the Microbiology Laboratory 3 separate times which did not identity the turbidity.
The FDA team has documented explained the observations in 5 separate sub points clearly marking this as the highly critical one.

Observation 7:

Responsibilities and procedures applicable to the quality control unit were not duly followed.

  • As per the SOP, a product recall needs to be carried out for failure to meet regulatory specification/ observation of quality defects, yet no market action was taken for a specific batch as well as another batch.
  • Failure to use forceps was the root cause of the turbid vial i.e. poor aseptic technique used. Both the actions were performed by the same Production Operator who was trained in aseptic technique. However, product impact assessment performed as part of the investigation failed to include a summary evaluation of personnel monitoring.
  • Established rules for personnel to follow good documentation practices during manufacturing were not adhered to as per the SOP.
  • Appropriate measures not taken to assure that batch records  include complete, original information relating to the production and control of each batch – initial implementation of Quality Check for variety of equipment usage and analytical raw data test reports were not included in the SOP.
  • In relation to the September, 2014 audit, a retrospective quality risk assessment of aseptic processes was performed.

Our Understanding: Non adherence to cGMP – Current Good Manufacturing Practices – something that the FDA expects every pharma manufacturing facility to comply with.

Observation 8:

Changes to written procedures are not drafted, reviewed and approved by appropriate organizational units.
Our Understanding: HEPA filter frequency changed for integrity testing was changed and not implemented according to a formal change control or as per Corrective Action Request.

Observation 9:

Appropriate controls are not exercised  to assure that changes to documents related to the manufacture of drug products are instituted only by authorized personnel.
Our Understanding: Source electronic data specifically related to Building Management System (BMS) unit prior to July 2015 has not been retained.

  • No data for sensor channels appears in the firm’s BMS system.
  • Source data and pdf reports for temperature recording not stored

While the FDA team has mentioned that appropriate controls were not exercised, the examples cited do not clearly signify the actions taken by unauthorized personnel.


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Our understanding signifies Observation 7 and 8 as highly critical. Even if Sun is able to take remediation steps for others observations, a re-inspection would be required so that the FDA has been assured that the plant would no longer have any cGMP issues including product recalls.
Considering FDA’s over arching schedule, this should take at least 6-8 months for handling the remediation.
The stock closed at Rs. 678.40/- which is even lower than what it was in September, 2014 and December, 2015.