INSPECTIONAL OBSERVATIONS - Forest/Inwood Laboratories, Inc.
ATTACHMENT #4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
850 Third Ave
Brooklyn, NY 11232
718/340-7000
NAME OF INDIVIDUAL TO WHOM REPORT ISSUED
Timothy Getek, Ph.D.
PERIOD OF INSPECTION
10/5 … 23/98
C.
F.
NUMBER
24-36921
TITLE OF INDIVIDUAL
Associate
Director Bioanalytical Lab.
TYPE ESTABLISHMENT
INSPECTED
Bioanalytical Lab
FIRM NAME
Forest/Inwood Laboratories, Inc.
NAME OF FIRM. BRANCH OR UNIT
INSPECTED
Same
STREET
ADDRESS
220 Sea
Lane
STREET
ADDRESS OF PREMISES INSPECTED
Same
CITY AND STATE (Zip
Code)
Farmingdale, NY
11735
CITY AND STATE (Zip
Code)
Same
DURING AN INSPECTION OF YOUR
FIRM (I) (WE) OBSERVED:
Observations were made regarding studies XXXX
R/5000/001, FLU-PK-03-000
(Rimantadine), and R/1700/004
(Isosorbide Dinitrate).
1. The
SOP #F-001
entitled "Analytical
Run
Acceptance Criteria"
is not objective in
that it permits calibration standards to be
deleted so that quality control (QC) value
will fall
within the acceptable limits. Examples include:
a) XXXX Stock Solution Stability:
Run
b)
XXXX Runs XXXX
2.
SOP #F-001
permits calculation of accuracy of QCs using the validated QC
value
as the true value, rather than using the theoretical
value. Calculation of accuracy
using the theoretical value as the true value
would result in the majority of QCs not
meeting the acceptance criteria in about 50%
of the analytical runs for XXXX and XXXX.
3. The reported assay precision in the analytical
runs was not accurate because the
precision analysis did not include the standards
and QCs which failed to meet the
acceptance criteria.
For example, inclusion of all standard values in XXXX
increased
the coefficient of variation (CV) for XXXX (from 2.5 -
10.2%
to 2.5-15.5%)
and for XXXX
(from 2.5-9.8%
to 2.5-12.0%).
Similarly, inclusion of all standard ,values
in XXXX increased
the CV
for
XXXX (from 3.6 - 9.6%
to 3.6 -18.3%)
and XXXX (from 2.2 -
8.0%
to 2.2 - 21.9%).
SEE
REVERSE OF THIS PAGE
EMPLOYEE(S) SIGNATURE
EMPLOYEE(S) NAME AND TITLE (Print or Type)
Lawrence Farina, Investigator
Gary Lehr, Chemist
DATE ISSUED
10/23/98
FORM FDA 483
(5/95) PREVIOUS EDITION MAY BE USED.
INSPECTIONAL OBSERVATIONS …
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