CIPLA gets 483 by U.S. FDA For Goa Unit | CIPLA 483 | FDA |

Cipla Ltd. received eight observations regarding manufacturing practices at its Goa plant that contributes a quarter of the drugmaker’s sales in the U.S.

The facility of India’s second-largest pharma company by market value was inspected from Jan. 22 -25, according to a Form 483 issued by the U.S. Food and Drug Administration.

Here are the eight U.S. FDA observations for the Goa plant:

• Failure to review out of specification investigation.
• Failure of documentation of batch production and control records.
• Laboratory records incomplete of all data obtained during testing.
• Establishment test procedures are not followed.
• No visual examination of reserve samples lots.
• Appropriate lab determination of drugs missing.
• Quality control procedures are not in writing and fully followed.
• Equipment not of appropriate design.

The first observation is a repeat and a little concerning while the others are procedural, said Praful Bohra of brokerage Equirus Capital. Cipla will have to explain to the U.S. FDA the difference in the conclusion tests for the plant to get cleared, he said.

Source: BloombergQuint

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