The regulator observed that the plant had not established control procedures and processes with respect to cleaning and maintenance were inadequate
Alembic Pharma plant gets USFDA Form 483
Alembic Pharma share price fell over 4 percent in intraday trade on December 16 following reports that the US Food and Drug Administration (USFDA) issued a Form 483 to the company’s Karkahadi plant in Gujarat.
CNBC-TV18 accessed the form and shared 10 observations issued by the US regulator after its inspection during October 28-November 10.
The regulator largely observed that the plant had not established control procedures and processes with respect to cleaning and maintenance were inadequate.
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The USFDA also said the procedures to prevent microbiological contamination were inadequate and that the plant did not maintain written records of investigations into unexplained discrepancies.
Verification of suitability of testing methods was deficient, and appropriate controls were not exercised over computers or related systems, the USFDA observed.
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The observations are likely to take time to resolve since it is a sterile injectable facility, said a source to CNBC-TV18. This Alembic Pharma facility is fairly new and has 10 injectable filings currently.
Analysts believe there are chances of escalation by the USFDA since one of the observations was repeated by the regulator.
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At 1.47 pm, the stock was trading 2.6 percent lower at Rs 770.55 on the BSE, though most pharma stocks were under pressure amid Omicron variant concerns in an overall choppy market.
