FDA has insured form 483 to Dr. Reddy's Laboratory | API | IDA Bollaram | GMP VIOLATIONS |
The US FDA has been inspected the Dr. Reddy's laboratory located at IDA Bollaram which is manufacturing of Active pharmaceutical ingredients. The form 483 has been issued with 5 observations.
OBSERVATION 1:
The responsibilities and procedures applicable to the Quality
control unit are not fully followed. Specially
A)
Your quality unit failure to close multiple
CAPAs within allowable timeframe and justification to extend the completion timeframe
was not requested. Specifically, your quality unit did not request an extension
to the few CAPAs.
B)
One of QC laboratory Audit trail reviewed and
found discrepancy which is having without logging incident. And proper justification
found.
C)
Failed to establish Quality agreements with starting
materials suppliers
D)
Failure to follow the Incident reporting system as per
your site SOP.
OBSERVATION 2:
Procedures describing the handling of written and oral complaints
related to API Materials are not followed.
A)
In adequate closure of market complaint closure without
tracking fulfillment.
B) Complaint investigation concluded with CAPA, no
CAPA has logged and not implemented the SOP revision.
OBSERVATION 3:
Building used in the manufacturing, processing, packing of
API finished materials are not maintained in a good state of repair.
As the facility containment not meeting as required.
OBSERVATION 4:
Separate or defined areas to
prevent contamination or mix-ups are deficient regarding operations related to
the quarantine storage of API finished materials prior to release.
OBSERVATION 5:
There is NO assurance that the equipment used in the
production of ___ and ___API are always maintained and kept in under proper conditions
for manufacturing operations and no prevent the contamination of the products.
A)
Failure to fulfil the record sheets as required
B)
A piece of fabric thread was observes the inside the filled container
C)
Presence of product was observed inside the
following production equipment.
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