Cipla in FDA trouble: During the 11-day inspection, the FDA uncovered inadequate cleaning practices

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Indian drugmaker Cipla informed the bourses that its finished pharmaceuticals manufacturing facility in Goa had been classified as Official Action Indicated (OAI) by the US Food and Drug Administration (FDA).

The facility was inspected in September 2019, following which the FDA investigators had issued a 38-page Form 483.

During the 11-day inspection, the FDA uncovered inadequate cleaning practices. During a facility walkthrough there were multiple instances where layers of colored drug product residue were observed on the inside surfaces of air outlet ducts.

In addition, the aseptic filling areas were not operating as per the established classification and were found to be deficient in systems for maintaining equipment used to control the aseptic conditions.

Cipla’s Goa unit generates 25 to 30 percent of its US business. However, the firm has stated that this development will not have any material impact on its US business.

Cipla also informed the bourses that it had received an EIR (Establishment Inspection Report) from the FDA for its Patalganga manufacturing facility in Maharashtra. The inspection was conducted from November 4 to 13, 2019.

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Meanwhile, Indian drugmaker Biocon shared a positive development that a pre-approval inspection of the Bengaluru facility of its subsidiary — Biocon Pharma — conducted by the FDA was concluded with zero observations.

The US agency had conducted a pre-approval inspection of the oral solid dosage manufacturing facility of Biocon Pharma, which was triggered by the submission of an abbreviated new drug application (ANDA), Biocon said in a regulatory filing.

“The inspection of the Bengaluru facility, which took place between January 13 and January 17, 2020, concluded with zero observations and no Form 483 was issued,” the company told stock exchanges.

Strides Pharma Science Ltd (Strides) said its arm has received an EIR from FDA for its Florida facility in the US. The inspection of the facility was conducted in December last year.

The facility is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs, it said.

Meanwhile, a news report pointed out that the total number of OAI classifications of the FDA continued to fall in 2019. A majority of the OAI’s issued by the FDA last year were for US-based facilities.

FDAs inspection classification database for the drug, device and biologic centers revealed that China and Indias share of the overall OAI classifications total has remained relatively steady over the past five years, while the US has seen a decline in the number of such classifications.


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