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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CASA Lab, Inc. 02-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
FAX: 504-253-4520

July 2, 2001

WARNING LETTER NO. 2001 -NOL-33
FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Jimmy N. Johnson, President
CASA Lab, Inc.
#2 Emu Lane
Silver Creek, MS 39663

Dear Mr. Johnson:

During May 15 through 18, 2001, an investigator of the U.S. Food and Drug Administration (FDA) conducted an inspection of your pharmaceutical and cosmetic manufacturing facility located at #2 Emu Lane, Silver Creek, Mississippi. The inspection was conducted to determine compliance with FDA?s Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211). Our investigator documented deviations from the regulations that cause your finished pharmaceuticals to be adulterated within the meaning of Section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The CGMP deviations documented during the inspection include, but are not limited to, the following:

Failure to establish a quality control unit;

Failure to ensure that all employees involved in the manufacturing of products have the required and necessary training and experience;

Failure to validate the cleaning of equipment used in drug product manufacturing process;

Failure to qualify or validate the manufacturing equipment used to manufacture your drug product(s);

Failure to identify drug product batches with a lot or control number that permits the determination of the history of the manufacture and control of the batch;

Failure to maintain records of labeling and/or packaging receipt, sampling, testing, and acceptance/rejection;

Failure to maintain a written record of equipment cleaning;

Failure to maintain master and/or batch production records;

Failure to maintain a complaint file or establish a complaint handling system; and,

Failure to establish or maintain standard written procedures for a quality control unit, equipment cleaning and maintenance, component control, manufacturing process, microbiological contamination control, control of labeling and packaging material, product warehousing and distribution, finished product testing, product stability program, and complaint handling.

The above violations, as well as the Form FDA 483, List of Inspectional Observations, issued to you at the close of the inspection, are not intended to be an all-inclusive list of deficiencies at your manufacturing facility. It is your responsibility to assure that your facility is operating in compliance with applicable requirements and regulations. It is also your responsibility to assure not only that the current objectionable conditions are corrected, but that appropriate policies and procedures are implemented to prevent recurrence of the problems. Failure to promptly make corrections could result in regulatory action without further notice. Possible actions include seizure and/or injunction.

Until such corrections have been made, Federal agencies will be advised of the issuance of this Warning Letter, so they may take this information into account when considering the award of contracts. Additionally, pending product or methods approval applications or export approval requests may not be approved until the above violations are corrected.

Our investigator also collected labeling for products that you manufacture. We are currently in the process of reviewing your product labeling and will address specific labeling issues in a follow-up letter. You should be aware that drugs must comply with all existing labeling requirements of Section 502 of the Act and in Title 21 of the CFR (21 CFR 201 ) and they must be manufactured by a registered facility and listed with FDA (21 CFR 207).

We are aware that at the close of our previous inspection of your facility, on November 9, 2000, you made a verbal commitment to correct observed deficiencies, which were substantially the same to those documented on May 18, 2001. You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent the recurrence of similar violations. Once corrective actions have been taken, forward to this office documentation necessary to verify that corrections have been achieved. If corrective action cannot be completed within 15 working days, please state the reason for the delay and the time by which the corrections will be completed.

Address your reply Compliance Officer, to the U.S. Food and Drug Administration, Attention: Ms. Rebecca A. Asente, at the address above.

Sincerely,

/s/
Carl E. Draper
District Director
New Orleans District