DEPARTMENT OF HEALTH AND lllJMAN SERVICF.S
FOOD AND DRUG ADMINISTRATION
~t1i(S) OFJN5PfCDON

12/07/2016-1211612016•

:r

Bhaskar Redd , Vice President 0 erations
S1Ul!rAlqESS ·.

Hetero Labs Limited
CITY, STATE, ZIP

TSilC Pharma SEZ

<XIUNTaY

TYPE ESTAlllJ&l9i8iNT INSP6ClED

Polepally Village, Jaddierla Mandal. Mahaboob Napr D&.
tri Telan ana
SOCJ301, India

Oral Solid Dote DrugProduct Manufacturer

This document lists obsemltioos made .by the FDA representatives dutjng the inspection of your facllity. They are iospectiooal observ8*ns. ~ do
represe1\t a 1iqa.1 Agenc)'.determination ~g&rdmg Y.OJlf compliance. If you have an objection
regarding IQ. observation, or have in.,Jplememed, or plan to iri:iplement, Corrective action in response to an observation, you
may discuss the o~jec~n or action with the FDA represeot8tiv4'5 during the. inspection or submit this .information to FDA at
the ad~ above. If..:Yoo have any qucstj~.
lbove.
'
.. please contact fDA at the~
. n~ber.~,ad~
. ,,
.

not.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1
The responsibilities and procedures applicable to the quality control unit are not fully followed.
(1) Specifically, your QA technicians and other individuals were reconied des1roying and altering reconis pertaining to commercial batch manufacturing immediately prior to this regulatory inspection. The
loss of data a00 documents are evidenced by the following:
Through a review of your firms Closed Circuit 1V we identified the following:

(a) A document shredder was introduced into your fmn's "IX>CUMENTS STORAGE AREA"
on December 03, 2016 at 15:44, approximately 4 days prior to the current US FDA impection.
(b) After introduction of the document shredder we observed extensive shredding of what appears to be controlled documents and extemive signing of documents by QA. These doclUllents
were of a color consistent with batch packaging reconis and batch manufacturing reconis, among
other documents. Your firm failed to maintain documentation of what bad been shredded.
M~

.

(c) On December 06, 2016, at
we observed that a contract employee with QA removed
documents from the shredder and placed them in his pocket
(d) On December 07, 2016, at approximately 1:13 (m the middle of the night) individuals were
shredding documents. Your finn stated this event represented cleaning staff shredding documents.

EMPLOYEl!(S)SK»IAlUU

SEE REVERSE
OF 1111S PAGE

Massoud Motamed, Invcstigato
Latorie S. Jones, Investigator

1211612016

M&l 1 Of U PMIES