|Subject:||Current Good Manufacturing Practice(CGMP)/Current Good Tissue Practice(CGTP)|
|Issuer:||Detroit District Office|
|Issued:||June 29, 2005||Closed:||
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
June 29, 2005
Mr. Ross A . Deardorff
CrestLab Inc. (dba Kingswood Laboratories Inc)
10375 Hagae Road
Indianapolis, IN 46256
Dear Mr. Deardorff:
The Food and Drug Administration (FDA) conducted an inspection of your facility on April 21st through 28th, 2005. The inspection covered your Moi-Stir Oral Swabstick products that are considered devices as defined by Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act).
The above-referenced inspection revealed that these devices are adulterated within the meaning of Section 501(h) (21 USC 3351(h))of the Act, in that the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformance with general current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulation (CFR), Part 820. Significant deviations include, but are not limited
to, the following:
1. Failure to investigate and determine the cause of the nonconformity as required by 21 CFR 820.1 00(a)(2). For example, the root cause of mold growth on the Moi-Stir Oral Swabsticks has not been determined. [See FDA-483 Observation 4].
2. Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50 . [See FDA-483 Observations 2 ].
3. Failure to establish an agreement from the contractor that they will notify you of changes in the product or services as required by 21 CFR 820.50(b). [See FDA-483 Observation 3].
This letter is not intended to be an all-inclusive review of your firm's compliance status. It is your responsibility to assure adherence to each requirement of the federal regulations. Other Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts.
We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of violative products, the assessment of civil money penalties, and for enjoining the manufacturer and/or distributor,of violative products.
We acknowledge receipt of the May 25, 2005 letter from you written in response to the FDA-483. The letter describes substantial commitments toward corrective action, and we are encouraged by the letter that you have already accomplished some of the corrections. However, we have carefully reviewed the letter and found that you have not determined the root cause of mold growth on the Moi-Stir Oral Swabsticks nor identified the actions needed to prevent reoccuriences (See item.#1). Without knowing the root cause, it is difficult to know if your corrective actions are satisfactory. In addition, the documents that you have submitted in response to Observation #2 on the Form FDA-483 do not adequately address how you will ensure that all purchased or otherwise received product conforms to specified requirements. Your response to Observation # 3 is also incomplete:
Please notify this office in writing within fifteen (15) working days of your receipt of this letter, as to the specific steps you have taken to correct these violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective actions cannot be completed within 15 working days; please state the reason for the delay and the time frame which the corrections will be implemented.
Your written reply should be directed to Paige E. Wilson, Compliance Officer at the above address.
Joann M. Givens
Detroit District Officer