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Last Updated : Jun 03, 2019 04:10 PM IST | Source:

Aurobindo Pharma slips 5% after detailed USFDA observations to unit 3

USFDA observed that responsibilities and procedures applicable to quality control unit are not in writing and fully followed

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Aurobindo Pharma shares fell nearly 5 percent intraday on June 3 after detailed USFDA observations for company's unit-3.

The stock was quoting at Rs 645.30, down Rs 27.45, or 4.08 percent on the BSE, at 1332 hours IST.

CNBC-TV18 accessed Form 483 issued by US Food and Drug Administration to company's unit-3 after inspection during May 13-24, 2019.


The unit-3 is a multi-product oral dosage form facility for non-cephalosporins and non-beta-lactams.

The unit had received 10 observations which are:

1) Responsibilities and procedures applicable to quality control unit are not in writing and fully followed;
2) Sample which is representative of each lot in each shipment of each active ingredient is not appropriately identified and retained;
3) Written procedures are not followed for cleaning and maintenance of equipment;
4) Lab records do not include complete data derived from all tests, examinations;
5) Written records of investigations into unexplained discrepancies do not always include conclusions, follow up;
6) Written record of investigations of drug complaint do not include findings of investigation and follow up;
7) Appropriate controls not exercised over computers or related systems to assure changes are instituted only by authorised personnel;
8) Back up data is not assured from alteration, erasure or loss;
9) Drug product expiration dates not related to storage conditions stated on labeling;10) Buildings used for drug products do not have suitable construction.

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First Published on Jun 3, 2019 04:10 pm
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