To, Date: 08.09.

2017
The Assistant Director
Export Inspection Agency-Chennai
S.O: Nellore, A.P.

Respected sir.

Sub:- Submission of the Corrective actions for the Non-conformity Report during APE for Renewal of
Approval on 28.08.2017 Reg:-
Ref:- Renewal Approval of M/s Munnangi Sea Foods Pvt Ltd with approval Number 1836 Validity up
to 17.09.2017

We, M/s Munnangi Sea Foods Pvt Ltd, with an approval no.1836, hereby acknowledge and
accept the non-conformity raised during your APE Renewal visit to our facility on 28.08.2017 and
hereby submitting the detailed Corrective Action taken to ensure that we comply to all the issues raised
in the Non-conformity Report.

The details of the Non-conformity raised and the Corrective actions taken are as follows

1. The In-house Laboratory involved in the testing of the Antibiotic residues (CAP/NFM) by
ELISA, however the samples are not analyzed in duplicate as recommended by the Kit
Manufacturer instructions.
The In-house Laboratory of Munnangi Sea Foods Pvt Ltd has started testing of the
Antibiotic residues (CAP/NFM) by duly keeping duplicate as recommended by the Kit
manufacturer and the copy of raw data and Calculation data of the testing process for the
Farm Sample lot of Raw material is enclosed for your kind perusal.

NC-1 Annexure -1(a, b, c ,d, e)

1. Copy of Raw data and Calculation data of Chloramphenicol and Nitro furan
Metabolites with duplicate analysis as recommended by test kits.

2. Quality Control Samples (Negative and Positive Controls) are not analyzed with each batch
during analysis.
The In-house Laboratory of Munnangi Sea Foods Pvt Ltd has started testing of the
Antibiotic residues (CAP/NFM) by duly keeping quality control samples (Negative and
Positive Controls) and the copy of raw data and Calculation data of the testing process for
the Farm Sample lot of Raw material is enclosed for your kind perusal.

NC-2 Annexure -2(a, b, c ,d, e)

1. Copy of Raw data and Calculation data of Chloramphenicol and Nitro furan
Metabolites with Negative and Positive analysis as recommended by the Standards.
3. The In-house Laboratory have two digital electronic balance, one used for Microbiological
(sample and media Weighing) and another one used for the Antibiotic (Sample and Chemical
Weighing), Same balance (Microbiology) should not be used for both the activities as concern
with Good Laboratory Manufacturing Practices and The weight measures and noted in weight
machine log book (Log book no. FMT/QC/163/01 & FMT/QC/163/02) are not traceable.

The In-house Good Laboratory Practice of weighing is changed by allocating one digital
electronic weighing scale for weighing of the Media and Chemicals separately and other
balance was allocated for weighing the samples of both Microbiological and Antibiotic
tests along with a proper cleaning procedures designed to prevent any cross contamination
between each process.

The Log book no. FMT/QC/163/01 & FMT/QC/163/02 are amended as per the
requirement of the changed Good Laboratory practices. The copy of the Good Laboratory
Practices and the Copy of changed Log Book FMT/QC/163/01 & FMT/QC/163/02 for
your kind perusal.

NC-3 Annexure -3
1. Copy of Obsolete FMT/QC/163/01 & FMT/QC/163/02 and the Amended Format
FMT/QC/163/01/A & FMT/QC/163/02/A is enclosed.

4. In-house Laboratory involving in the testing of E.coli and Fecal Coli form in water and Ice
Sample as well as Salmonella in finished Products, as per the SOP (For Fecal Coliform &
E.coli EIJKMAN Test) It has to be incubated at 45.5 Degree centigrade and Secondary
Enrichment Medium of Salmonella Analysis (RV Medium) has to be Incubated at 42 Degree
Centigrade, Laboratory is having only one water bath (Set Temperature 42 Degree
Centigrade). The Facility for the Incubation of E.coli EIJKMAN Test and BGLB Broth for
Fecal Coliform at 44.5 Degree Centigrade is not available.

As the Secondary Enrichment Medium of Salmonella Analysis (RV Medium) is a

daily testing parameter and has to be Incubated at 42C, we fixed the Water bath with
at a set temperature of 42C and is in use. The other Water bath allocated for the
Incubation of E.coli EIJKMAN Test and BGLB Broth for Fecal Coli form at 44.5
Centigrade required only when the suspected colonies was noted, is sent for an repair
and we with immediate effect has purchased new Water bath and duly installed in the
Laboratory.

NC-4 Annexure -4
1. Picture of two water baths with different set temperature is enclosed.
 5. Laboratory is using the RV medium (Selective medium for Salmonella as per BAM) however
the sterilization of the Medium is not being done as per manufacturer instructions (Temp 115
Degree centigrade 15 Minutes)

The Sterilization of the RV medium (Selective medium for Salmonella as per BAM)
will be carried out as per manufacturer instructions (Temp 115 C 10 lbs15 Minutes)
separately and all the other Media sterilization at Temperature and pressure as per
manufacturer instructions

NC-5 Annexure -5
1. The Autoclave Log FMT/QC/165/01/A for Sterilization is enclosed.

6. The In-house Laboratory is having two Bacteriological incubator and one BOD incubator,
One Bacteriological Incubator used for the incubation of Microbiological samples (Set
temperature 37 degree centigrade) and another one for incubation of Antibiotic samples and
BOD incubator for the Incubation of water/Ice Sample (TPC at 22 Degree Centigrade).
However the facility for the incubation of the Listeria Monocytogenes at 30 Degree Centigrade
is not available.

The facility has three Incubator and a BOD Incubator as per the requirements of the
standards but was not present during the inspection due to the break-down of one
Incubator and we with immediate effect replaced the Incubator duly getting repaired
and the copy of incubator log is enclosed for your kind perusal.

NC-6 Annexure -6(a & b)

1. The Picture of the Three Autoclave with the set temperatures enclosed. (a)
2. Copy of Incubator Log FMT/QC/014/01 (b)

Please kindly seek for any further clarification required in this regards.

Thanking you

Yours Sincerely

Devaraj.Subramanyam
General Manager.