Dr. Reddy's Laboratories Louisiana LLC – FDA EIR, Aug 8, 2019

An FDA Pre-Approval Inspection of Dr. Reddy's Laboratories Louisiana LLC in Shreveport, LA, was conducted from August 5-8, 2019. This inspection was for Abbreviated New Drug Application (ANDA) 213473, covering Methylphenidate HCL in various strengths, under the regulatory framework of the FD&C Act. Although no FDA-483 was issued, the inspection highlighted several significant issues. Key observations included the operation of manufacturing equipment outside its validated operational parameters, with the firm using this non-compliant data in its submission. Another concern was batch records that documented "expected weight" as "actual weight" due to scales lacking raw data printouts, raising questions about data accuracy. Furthermore, final product quality control testing was performed prior to in-process quality control for the same batch, which the FDA investigator noted as compromising data integrity. Lastly, the company was not evaluating or trending rejects from a critical manufacturing process to assess process capability. In response, Dr. Reddy's management committed to considering and correcting the batch record issues. They stated that the practice of assaying final products before in-process samples would not continue for commercial production and that the equipment malfunction was corrected, although the FDA pointed out delays in addressing this. The firm also promised to consider trending reject bin contents. Despite these issues, the FDA concluded the firm appeared capable of manufacturing the drug product for commercialization, pending necessary corrections.