USFDA observed that responsibilities and procedures applicable to quality control unit are not in writing and fully followed
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.Subscribe to Moneycontrol Pro and gain access to curated markets data, exclusive trading recommendations, independent equity analysis, actionable investment ideas, nuanced takes on macro, corporate and policy actions, practical insights from market gurus and much more.