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U.S. Department of Health and Human Services

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Enforcement Actions

Crystal Laboratory, Inc. 06-Aug-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Rockville MD 20857


August 6, 2004

CBER-04-013

WARNING LETTER

Karl T. White
Crystal Laboratory, Inc.
Post Office Box 9
Luther, Oklahoma 73504

Dear Mr. White:

The Food and Drug Administration (FDA) conducted an inspection of Crystal Laboratory, Inc., 116 Main Street, Luther, Oklahoma, on May 5 through 7, 2004. During the inspection, FDA investigators documented violations of Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act), Section 351 of the Public Health Service Act (PHS Act), 42 U.S.C. Section 262, and deviations from the applicable standards and requirements of Subchapter F Parts 600 and 680, Title 21 Code of Federal Regulations (21 CFR). Deviations noted on the Form FDA 483, Inspectional Observations, issued at the conclusion of the inspection include, but are not limited to, the following:

1. You failed to follow current good manufacturing practice and applicable standards for the manufacture of of allergenic mold source material, [21 CFR 680.1(b)(2)(iii)]. For example, you failed to maintain and follow written standard operating procedures prescribing adequate processing of mold used as a source material for allergenic products. On four occasions since March 2003, you released mold source material for further manufacture that did not meet the specification of "no viable organisms ," in your Standard Operating Procedure (SOP) entitled “MOLDS.” In addition, while the records for the four lots indicate that there was growth on the viability plates, the Certificates of Analysis for the a two lots that were shipped to licensed allergenic manufacturers documented the results as "non-viable".

2. You failed to ensure that your personnel have capabilities commensurate with their assigned functions, a thorough understanding of the operations which they perform, the necessary training and experience relating to individual products, and adequate information concerning the applicable of the pertinent provisions of this subchapter to their respective functions [21 CFR 600.10(b)]. For example, on the four occasions mentioned in item 1 above, the person performing the viability test indicated "FUNGI NON VIABLE" on the production records, despite the existence of growth on the viability plates. A second employee verified those entries and signed the four production records, indicating that the viability test results were checked and found to be accurate. In addition, the employee who performed the viability tests signed two certificates of analysis, describing the results of the viability tests as “Non-viable.”

In addition, we note that during a teleconference between FDA and Crystal Labs, conducted on June 21, 2004, you agreed to:

  • Identify to the species level colonies that grow during the viability test to determine whether the colonies are contaminants or source organisms; and
  • Supplement SOP # 4, entitled, “MOLDS,” to include appropriate instructions for mixing of test samples and appropriate action for test failures and retesting.

Neither this letter nor the list of inspectional observations (Form FDA 483) is meant to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as a source material supplier to ensure that your operations are in full compliance with all applicable federal laws and regulations.

Please notify us in writing within 15 working days of receipt of this letter, of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. lf corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Failure to promptly correct these deviations may result in regulatory action without further notice. Your reply should be sent to James S. Cohen, J.D., Acting Director, Office of Compliance and Biologics Quality, the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 North, Rockville, Maryland 20852-1448.

If you have any questions regarding this letter, please contact Ms. Mary Malarkey, Director, Division of Case Management, at (301) 827-6201.

Sincerely,

/s/

David K. Elder
Director
Office of Enforcement