Inspections, Compliance, Enforcement, and Criminal Investigations
GOJO Industries Inc 21-Feb-02
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
February 21, 2002
Mr. Joseph Kanfer, President/CEO
GOJO Industries, Inc.
One GOJO Plaza, Suite 500
P.O. Box 991
Akron, OH 44309
On January 7-l0, 14, 18/2002 an FDA Investigator conducted an inspection of your over-the-counter (OTC) drug manufacturing facility at 3783 State Road, Cuyahoga Falls, OH 44223.
The investigator documented serious deviations from the current Good Manufacturing Practices (CGMPs) for drug products, Title 21 Code of Federal Regulations, Part 211 (21 CFR, Part 211). These deviations cause your OTC drug products Purell and Hand Medic III to be adulterated within the meaning of Section 501 (a)(2)(B) of the Federal Food Drug and Cosmetic Act (the Act). The deviations observed during the inspection included:
1. Mixing speeds, mixing times and automated re-circulation valve adjustments on production [mix] tanks are made by operators via a PLC control panel.
- There is no system in place to insure that parameter adjustments, which are executed during production runs, are made by authorized personnel. [21 CFR 211.68(b)]
- There are no SOPS or records documenting that the automated re-circulation valves and mixer speeds have been inspected and/or calibrated since the initial equipment qualification 2.5 years ago. [21 CFR 211.100]
c) There are no SOPS describing the frequency with which the mix tank? s temperature
monitoring systems should be calibrated. Records indicate that the temperature monitoring devices on mix tanks 122, 123, 131 have not been calibrated. [21 CFR 211.100 and 211.58(a)]
2. Batch records do not always document that mixing times (start/end), mixing speeds, and temperatures are adjusted according to the specified formulation range. [21 CFR 211.l88]
3. Fourteen of the 31 OTC drug formulations have no process validation. The remaining 17 formulations have had mix studies completed but final product fill has not been validated. [21 CFR 211.100 and 211.110]
4. The quality assurance unit operations are deficient in that:
- Complete written records of root cause investigations and corrective actions for processing discrepancies/failures are not maintained. b) There is no formal SOP describing how investigations and root cause determinations are reviewed/approved and how corrective actions are monitored for timely implementation. [21 CFR 211.22(a), 211.22(d) and 211.192].
5. Two lots of GOJO Hand Medic III [165461, 166095l] were released that had final product test results that were out of specification. A complete investigation into the root cause of the problem was not completed before product release. [21 CFR 211.165(f) and 211.192].
6. Products with out of specification active ingredient assays are reworked. The rework procedures have not been validated. [21 CFR 211.15, 211.100 and 211.110].
7. Product stability procedures/implementation:
a) The stability SOP does not specify how soon after the end of manufacturing samples should be pulled and placed on stability.
b) Stability SOP sampling procedures are not always followed.
1) The smallest fill size of each container-closure system is not always placed on an annual long- term stability-testing program.
2) Two sets of stability samples were pulled for a lot of Purell [l25358] packaged in a 500-ml bag/box closure system. Both sets of samples were outside of your firm?s stability range [60%] and were below the label claim [62%] 21 months after the manufacture date. The expiration period for this product is 24 months. There was no documented investigation as to why two sets of samples were placed on stability and why both sets of samples fell out of specification before the expiration date. [21 CFR 211.166].
8. Your cleaning procedures have not been validated. There are 12 production [mix] tanks and 19 hold tanks. Only one OTC formulation has a dedicated mix tank. None of the hold tanks are product specific. [21 CFR 211.67]
9. The water systems used in the production of OTC drug products have not been validated. [211.100 and 211.110]
This letter is not intended to be an all-inclusive listing of deviations at that your firm. It is your responsibility to ensure that all products (including all labeling and promotional materials) distributed by your firm are in compliance with the Act and its implementing regulations.
You should take prompt action to correct these violations. Failure to achieve prompt correction may result in regulatory action without further notice. Possible actions include seizure and/or injunction.
Until these violations are corrected, federal agencies will be informed that FDA recommends against award of contracts for the affected products.
We acknowledge the receipt of the letter dated February 11, 2002 -from Mark S. Werner, Chief Operating Officer responding to the FDA-483 that was issued at the conclusion of the inspection. The responses to FDA-483 items #3, #5, #6, #7, #8 and #9 fail in al1 respects to adequately address the deviations noted by the investigator.
The effectiveness of your actions to correct the remaining items (#1, #2, and #4) cannot be verified without reviewing documentation such as newly written standard operating procedures and the various records/logs associated with those procedures.
You are invited to meet with us in our office here in Cincinnati so that we can further discuss the deficiencies we noted with your response letter. You should contact Stephen Y. Rabe, Compliance Officer at the number listed below to arrange a meeting time that is convenient for all parties involved.
Whether or not you decide to accept our offer to meet with you, you should notify this office in writing within fifteen (15) working days of receipt of this letter of the specific actions you are taking to address these deviations. You should include an explanation of each step being taken to prevent recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your written reply and any supporting documentation should be addressed to the U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097, Attention: Stephen J. Rabe, Compliance Officer. Any questions regarding this letter or other issues may be directed to Mr. Wabe at 513-679-2700 extension 167.
Henry L. Fielden