Establishment Inspection Report · Establishment Inspection Report Coating Systems Laboratories,...

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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 TJ 1Y , '-"-.-.....~,.~ OJ> ~lonza E. Cruse District Director Enclosure dso

Transcript of Establishment Inspection Report · Establishment Inspection Report Coating Systems Laboratories,...

Page 1: Establishment Inspection Report · Establishment Inspection Report Coating Systems Laboratories, Inc Chandler, AZ 85225-1107 FEI: EI Start: EIEnd: 3005368257 0212612010 02126/2010

DEPARTMENT OF HEALTH AND HUMAN SERVICE Public Health Service

Food and Drug AdministrationLos Angeles DistrictPacific Region19701 FairchildIrvine, CA 92612

APR - 2 2010Telephone: 949-608-2900

FAX: 949-608-4415

William R. Peterson, Ph.D., CEOCoating 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 atyour facility located at Coating Systems Laboratories, Inc., 211 E. Chilton Dr., Chandler, AZ onFebruary 26, 2010 by Investigator Timothy T. Kapsala on b~half of the U.S. Food and DrugAdministration (FDA). When the agency concludes that an inspection is closed under Title 21, Code ofFederal Regulations, Section 20.64(d)(3), it will release a copy of the EIR to the inspectedestablishment.

The Agency is working to make its regulatory process and activities more transparent to the regulatedindustry. Releasing this EIR to you is part of this effort. The copy being provided to you comprises thenarrative portion of the report; it reflects only first party redactions made by the Agency which protectsany confidential information external to your firm. This, however, does not preclude you fromrequesting 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 writeto:

u.s. Food and Drug Administration19701 FairchildIrvine, CA 92612

TJ1Y

, '-"-.-.....~,.~ OJ>

~lonza E. CruseDistrict Director

Enclosure

dso

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Establishment Inspection ReportCoating Systems Laboratories, IncChandler, AZ 85225-1107

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TABLE OF CONTENTS

Summary 1Administrative Data 2History 2Interstate Commerce 2Individual Responsibility and Persons Interviewed 3Firm's Training Program 3ManufacturinglDesign Operations 4Manufacturing Codes 6Complaints 6Refusals 7Exhibits Collected 7Attachments 7

SUMMARY

This abbreviated inspection (routine coverage) of a topical drug manufacturer was conducted underFY 10 workplans, and CPo7356.002 (Drug Manufacturing Inspections). This abbreviated inspectionfocused on the quality and production systems. The last inspection was conducted on 817107 and wasclassified 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 alsomanufactures a bulk hand sanitizer product. This inspection focused on the hand sanitizer (topicaldrug 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 anFDA-483. No samples were collected.

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Establishment Inspection ReportCoating Systems Laboratories, IneChandler, AZ 85225-1107

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ADMINISTRATIVE DATA

Inspected firm:Location:

Phone:FAX:Mailing address:

Dates of inspection:Days in the facility:Participants:

Coating Systems Laboratories, Inc211 E Chilton DrChandler, AZ 85225-1107480-503-0267480-503-4628211 E Chilton DrChandler, AZ 85225-1107

2126120101Timothy T Kapsala, Investigator

Currently the office hours and plant operations are from 9:00 am to 5:00 pm Monday throughFriday. The firm employs five people.

The firm is registered as a drug manufacturer with the drug registration number of 3005368257. Theregistration was found to be current (Refer to exhibit #1).

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Credentials were shown and notice of inspection was issued to William R. Peterson Ph.D., CEO andmost responsible person at the firm. The majority of the information contained in this report wasprovided by William R. Peterson Ph.D., CEO.

HISTORY

This is the only facility and has been at this location since March of 2000. Coating SystemsLaboratories Inc. is incorporated in the state of Arizona.

INTERSTATE COMMERCE

Approximately 99% of the firm's products are introduced into interstate commerce. This firm'soperations are 100% wholesale. The firm own labels all its products. The hand sanitizer (GERMFREE 24) product is shipped oversees. The firm's primary customer is the Zoono Group ofCompanies located in New Zealand and Australia.

Currently the firm's hand sanitizer (refer to exhibit #2) is shipped by container on a ship. Theproduct cannot be shipped by air because the product freezes at _4°C.

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This facility also manufactures tile and masonry sealants and stains, which are not FDA regulated (Acomplete 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 andmost responsible person at the firm.

Key operating personnel and their functions/responsibilities are as follows:

William R. Peterson Ph.D., CEOResponsibilities include the following: Mr. Peterson is the most responsible person at the firm. Heoversees the entire company, performs quality control, manufacturing, writes SOP's, prepares rawmaterial inventory specifications and allocates resources. Mr. Peterson also co-owns the businesswith Renee E. Berman, CFO.

Renee E. Berman, CFOResponsibilities 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 ManagerResponsibilities include the following: Oversees production and performs raw material and finishedproduct 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. Peterson211 E. Chilton DriveChandler, AZ 85225

FIRM'S TRAINING PROGRAM

Training is performed by William R. Peterson Ph.D., CEO. Structured on the job training isconducted combined with a training/review of the firm's SOP manual.

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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 andthen shipped oversees. The majority of the hand sanitizer is shipped to the Zoono Group ofCompanies located in New Zealand and Australia. The Zoono Group of Companies will then bottlethe 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 doorand 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.

tAfter 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.

tThe lot number then gets placed into the computer system for the product Germ Free 24.

tThe product is compounded into 55 gallon bulk HOPE plastic drums, weighed and labeled.

tA finished product assay is performed for the quaternary (density and appearance).

tA retain sample is taken and stored.

tFinished 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 completeprocess 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 Deionizingtank to remove minerals in the water. The water then flows through a 0.2 micron filter to remove

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pathogens (i.e. Pseudomonas) and finally (prior to compounding) a UV sterilizer is used. The UVsterilizes 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 gallonfinished product drums) and a 5000 gram Setra scale (used to weigh the quat and fragrance duringcompounding). All scales were recently calibrated (2122/10) by Accurate Scale and Equipmentlocated in Scottsdale, AZ.

Labels

Germ Free labels are affixed to the drums and contain the product name and lot number. Only oneproduct 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 werefound (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 foundand 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 toexhibits 7, 8 and 9). In addition, the firm has a procedure in place to capture the pertinentinformation from the C of A's that are received (refer to exhibit #10). The firm (Coating SystemsLaboratory) will also provide a finished product C of A to their consignees.

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The following in-house finished product assays are performed:

• Identity: Identity consists of the following (refer to exhibit #11 for procedure):1. Density2. Water solubility3. HazelN 0 Haze

• Quantitative: Used to test that the active (Quat) binds to the substrate or surface that the productis 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 iscollected in a PET (polyethylene terpthalate) plastic bottle. Glass bottles react with the product. Theretain samples include the lot number, person who collected the sample and date of manufacture.

MANUFACTURING CODES

The firm follows the following code system:

Example: 9117759= the year 200911;:::themonth November775 is a sequential manufacturing product number (sequential for all products that aremanufactured).

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 toexhibit #12 for the complaint form/procedure.

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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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