APR - 2 2010

DEPARTMENT OF HEALTH AND HUMAN SERVICE
Public Health Service
Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612
APR - 2 2010
Telephone: 949-608-2900
FAX: 949-608-4415
William R. Peterson, Ph.D., CEO
Coating Systems Laboratories, Inc.
211 E. Chilton Dr.
Chandler, AZ 85225-1107
Dear Dr. Peterson:
We are enclosing a copy of the establishment inspection report (EIR) for-the inspection conducted at
your facility located at Coating Systems Laboratories, Inc., 211 E. Chilton Dr., Chandler, AZ on
February 26, 2010 by Investigator Timothy T. Kapsala on b~half of the U.S. Food and Drug
Administration (FDA). When the agency concludes that an inspection is closed under Title 21, Code of
Federal Regulations, Section 20.64(d)(3), it will release a copy of the EIR to the inspected
establishment.
The Agency is working to make its regulatory process and activities more transparent to the regulated
industry. Releasing this EIR to you is part of this effort. The copy being provided to you comprises the
narrative portion of the report; it reflects only first party redactions made by the Agency which protects
any confidential information external to your firm. This, however, does not preclude you from
requesting any additional information under the Freedom of Information Act (FOI).
If there are any questions about released information feel free to contact me at (949) 608-2900 or write
to:
u.s. Food
and Drug Administration
19701 Fairchild
Irvine, CA 92612
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E. Cruse
District Director
Enclosure
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Establishment Inspection Report
FEI:
3005368257
Coating Systems Laboratories, Inc
EI Start:
0212612010
EIEnd:
02/26/2010
Chandler, AZ 85225-1107
TABLE OF CONTENTS
Summary
1
Administrative Data
2
History
Interstate Commerce
2
2
Individual Responsibility and Persons Interviewed
Firm's Training Program
3
3
ManufacturinglDesign Operations
Manufacturing Codes
4
6
Complaints
6
Refusals
Exhibits Collected
Attachments
7
7
7
SUMMARY
This abbreviated inspection (routine coverage) of a topical drug manufacturer was conducted under
FY 10 workplans, and CPo 7356.002 (Drug Manufacturing Inspections). This abbreviated inspection
focused on the quality and production systems. The last inspection was conducted on 817107 and was
classified as NAI. The FACTS assignment number is 1131160. The profile class is the following:
OIN (non-sterile, which includes cream, jelly and paste).
This facility primarily manufactures tile and masonry sealants and stains. This firm also
manufactures a bulk hand sanitizer product. This inspection focused on the hand sanitizer (topical
drug product). The firm was not manufacturing during my inspection.
At the conclusion of this inspection, no observations were found and the firm was not issued an
FDA-483. No samples were collected.
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Establishment Inspection Report
Coating Systems Laboratories, Ine
Chandler, AZ 85225-1107
ADMINISTRATIVE
Inspected firm:
Location:
Phone:
FAX:
FEI:
EI Start:
3005368257
EIEnd:
02/2612010
02/2612010
DATA
Coating Systems Laboratories, Inc
211 E Chilton Dr
Chandler, AZ 85225-1107
480-503-0267
480-503-4628
Mailing address:
211 E Chilton Dr
Chandler, AZ 85225-1107
Dates of inspection:
Days in the facility:
Participants:
212612010
1
Timothy T Kapsala, Investigator
Currently the office hours and plant operations are from 9:00 am to 5:00 pm Monday through
Friday. The firm employs five people.
The firm is registered as a drug manufacturer with the drug registration number of 3005368257. The
registration was found to be current (Refer to exhibit #1).
I
Credentials were shown and notice of inspection was issued to William R. Peterson Ph.D., CEO and
most responsible person at the firm. The majority of the information contained in this report was
provided by William R. Peterson Ph.D., CEO.
HISTORY
This is the only facility and has been at this location since March of 2000. Coating Systems
Laboratories Inc. is incorporated in the state of Arizona.
INTERSTATE COMMERCE
Approximately 99% of the firm's products are introduced into interstate commerce. This firm's
operations are 100% wholesale. The firm own labels all its products. The hand sanitizer (GERM
FREE 24) product is shipped oversees. The firm's primary customer is the Zoono Group of
Companies located in New Zealand and Australia.
Currently the firm's hand sanitizer (refer to exhibit #2) is shipped by container on a ship. The
product cannot be shipped by air because the product freezes at _4°C.
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Establishment Inspection Report
FEI:
3005368257
Coating Systems Laboratories, lnc
El Start:
02126/2010
Chandler, AZ 85225-1107
ElEnd:
02/2612010
This facility also manufactures tile and masonry sealants and stains, which are not FDA regulated (A
complete list of products is found in exhibit #3).
INDIVIDUAL RESPONSIBILITY
AND PERSONS INTERVIEWED
Credentials were shown and notice of inspection was issued to William R. Peterson Ph.D., CEO and
most responsible person at the firm.
Key operating personnel and their functions/responsibilities
are as follows:
William R. Peterson Ph.D., CEO
Responsibilities include the following: Mr. Peterson is the most responsible person at the firm. He
oversees the entire company, performs quality control, manufacturing, writes SOP's, prepares raw
material inventory specifications and allocates resources. Mr. Peterson also co-owns the business
with Renee E. Berman, CFO.
Renee E. Berman, CFO
Responsibilities include the following: Purchasing, inventory, accounting and regulatory affairs.
Ms. Berman also co-owns the business with William R. Peterson Ph.D., CEO.
Daniel Berman, Operations Manager
Responsibilities include the following: Oversees production and performs raw material and finished
product assays. Daniel Berman reports to William R. Peterson Ph.D., CEO.
William R. Peterson, III; Sales Associate. Mr. Peterson, III performs all the sales functions. Mr.
Peterson, III reports to William R. Peterson Ph.D., CEO.
FMD-145: All correspondence pertaining to this inspection should be addressed to:
William R. Peterson
211 E. Chilton Drive
Chandler, AZ 85225
FIRM'S TRAINING PROGRAM
Training is performed by William R. Peterson Ph.D., CEO. Structured on the job training is
conducted combined with a training/review of the firm's SOP manual.
3 of7
Establishment Inspection Report
FEI:
3005368257
Coating Systems Laboratories, Inc
EI Start:
02/2612010
EIEnd:
02/26/2010
Chandler, AZ 85225-1107
MANUFACTURINGIDESIGN OPERATIONS
This 5200 square foot facility is housed in one building and includes offices, warehouse, receiving,
and a filling area. The hand sanitizer (Germ Free 24) is manufactured in bulk 55 gallon drums and
then shipped oversees. The majority of the hand sanitizer is shipped to the Zoono Group of
Companies located in New Zealand and Australia. The Zoono Group of Companies will then bottle
the finished product (Germ Free 24) into 200 mL and 50 mL spray bottles.
The general manufacturing process for Germ Free 24 is as follows: Bulk Raw Material (Quaternary, Ethanol and fragrance) are received in the firm's receiving bay door
and placed into a quarantined receiving area until the materials are verified against the P.O. (lot
numbers, product codes, etc) and the raw material assay meets specifications.
t
After an approved raw material assay and review, then a green approved sticker gets placed on the
raw material container and an internal lot number is generated.
t
The lot number then gets placed into the computer system for the product Germ Free 24.
t
The product is compounded into 55 gallon bulk HOPE plastic drums, weighed and labeled.
t
A finished product assay is performed for the quaternary (density and appearance).
t
A retain sample is taken and stored.
t
Finished product is shipped out of the firm's distribution bay door.
CompoundinglFillinglProduction
Compounding/filling is performed in a 55 gallon HOPE drum using filtered DI water. The complete
process is found in SOP GFMP 002 (Refer to exhibit #4).
DI/Water System
The firm has its own DI water system. City/municipal water is run through a PURETEK Deionizing
tank to remove minerals in the water. The water then flows through a 0.2 micron filter to remove
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Establishment Inspection Report
FEI:
3005368257
Coating Systems Laboratories, Inc
EI Start:
0212612010
EIEnd:
02126/2010
Chandler, AZ 85225-1107
pathogens (i.e. Pseudomonas) and finally (prior to compounding) a UV sterilizer is used. The UV
sterilizes the water at a rate of 10 gallons a minute.
ScaleslEquipment
The firm has the following production scales: 500 lb Ohaus floor scale (weighs the 55 gallon
finished product drums) and a 5000 gram Setra scale (used to weigh the quat and fragrance during
compounding). All scales were recently calibrated (2122/10) by Accurate Scale and Equipment
located in Scottsdale, AZ.
Labels
Germ Free labels are affixed to the drums and contain the product name and lot number. Only one
product is filled at one time, which greatly reduces label mix-ups.
Change Control
The firm does have a change control procedure in place, which I reviewed. No discrepancies were
found (refer to exhibit #5).
Product SheetlProduction Records
The firm fills an average of 10 filling runs a year ranging in size from four to eight 55 gallon drums.
I reviewed the following lot number for the hand sanitizer: 805560. No discrepancies were found
and the production sheet contained all the necessary elements.
SOP's
Refer to exhibit #6 for a list of the firm's SOP's.
C of A' slLaboratory
The firm will receive a C of A from the manufacturer for each lot of raw material received (refer to
exhibits 7, 8 and 9). In addition, the firm has a procedure in place to capture the pertinent
information from the C of A's that are received (refer to exhibit #10). The firm (Coating Systems
Laboratory) will also provide a finished product C of A to their consignees.
I
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RstabHshlllent Inspection Report
FEI:
300536S251
Coating Systems Laboratories, Inc
EI Start:
0212612010
Chandler, AZ 85225-1107
EIEnd:
02126/2010
The following in-house finished product assays are performed:
•
Identity: Identity consists of the following (refer to exhibit #11 for procedure):
1. Density
2. Water solubility
3. HazelN
•
0
Haze
Quantitative: Used to test that the active (Quat) binds to the substrate or surface that the product
is sprayed on. The test is performed in the following manner:
1. Spray product on a cotton substrate.
2. Add dye.
3. The dye will only bind to the quat.
4. The cotton is rinsed with water to remove unbound dye.
5. The bound dye (on quat) will be visible.
Retains
~.
The firm collects retains on every lot of product that they manufacture. A two ounce sample is
collected in a PET (polyethylene terpthalate) plastic bottle. Glass bottles react with the product. The
retain samples include the lot number, person who collected the sample and date of manufacture.
MANUFACTURING
CODES
The firm follows the following code system:
Example: 911775
9= the year 2009
11;:::themonth November
775 is a sequential manufacturing product number (sequential for all products that are
manufactured).
COMPLAINTS
William R. Peterson Ph.D., CEO stated that the firm has never had a complaint of injury or illness.
The complaint form was reviewed and contained all the necessary complaint elements. Refer to
exhibit #12 for the complaint form/procedure.
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3005368257
Establishment Inspection Report
FEI:
Coating Systems Laboratories, Inc
EI Start:
02/26/2010
EIEnd:
02/26/2010
Chandler, AZ 85225-1107
REFUSALS
There were no refusals.
EXHIBITS COLLECTED
1. Drug registration.
2. Germ Free 24 labels.
3,,- Product list.
_
4. Manufacturing procedure for Germ Free (two pages).
5. Completed change request form.
6. SOP list.
7. C of A for ethanol.
8. C of A for quaternary.
9. C of A for fragrance.
10. Incoming raw material log.
11. Ethanol raw material identity test form.
12. Complaint form/procedure (six pages).
ATTACHMENTS
1. 1. FDA-482 issued to William R. Peterson Ph.D., CEO.
Timothy T Kapsala, Investigator
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