The Form 483 states that India-based manufacturer Dr Reddy’s Laboratories received complaints from its clients regarding active pharmaceutical ingredients (API) presenting low assay (anhydrous basis), microbiological failures, high water content and loss on drying, stemming from its Bollaram, Hyderbad site.
According to the US Food and Drug Administration (FDA) the company’s investigations did not determine root causes for the drug substance failures. Instead, the company accepted the returned material without an adequate investigatory conclusion and reprocessed the material upon return.
The site also failed to evaluate whether the finished APIs and retention samples stored in areas where relative humidity is not controlled or monitored “are affected by extreme fluctuations in humidity,” the FDA noted.
“You have not adequately assessed whether the uncontrolled humidity conditions can affect the quality, purity and potency of your finished APIs and API retention samples during long-term storage,” the regulatory agency added.
Additionally, the FDA stated it received ‘several complaints’ according to which customers were shipped the wrong type of finished API, which led to the conclusion that the facility’s tracing system is not adequate.
The agency also observed that it allowed the site’s personnel to collect photographs from materials stored in the company’s warehouses “using explosion proof cameras”, although the photos “came back incomplete, blurry, partially captured, or not at all.”
“It took three attempts to collect all of the requested photos and during the second attempt we directly observed one of [the company’s] employees capturing photos using his cellular telephone despite your instruction to us that we were not allowed to have cellular phones in that area,” the Form 483 outlined.
The manufacturing plant for in Bollaram, Hyderabad, had previously received another Form 483 by FDA in 2018.
The company has also been issued with Forms 483 regarding other facilities, including a facility in Yorkshire, UK, in Duvvada, India and two more Forms 483 for its plants in Bachupally, India in 2017 and earlier this year.