APR - 2 2010
Transkript
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 TJ 1Y , ~lonza E. Cruse District Director Enclosure dso '-"-.-.....~,.~ OJ> 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. 10f7 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. 20f7 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 40f7 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 50f7 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. 60f7 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 70f7