Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm367140
Timestamp: 2019-02-20 09:27:04
Document Index: 445817745

Matched Legal Cases: ['§ 321', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360']

Standard Textile Co Inc 5/7/13
CIN-13-394883-21
Gary L. Heiman, President & CEO
Dear Mr. Heiman:
During an inspection of your firm located in Cincinnati, OH on February 4 through February 8, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a circumcision drape and other surgical drape products. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Our inspection revealed that the circumcision drape and other surgical drapes manufactured with the “barrier supreme” material, are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).
The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k) and 21 C.F.R. 807.81(a)(3)(i). Specifically, you have modified the circumcision drape and other surgical drapes, which according to your firm were pre-1976 amendment Class II devices, by changing the “barrier supreme” device material from (b)(4) to (b)(4) in 1994. This change in the device material as reported to our investigator would make it necessary for you to complete performance testing to assure the barrier properties of your devices had not been affected and that there are no new risks as a result of the material modification. Such changes require a new 510(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]
The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to all applicable FDA regulations and the Act. You should take prompt action to correct these violations. Failure to correct this violation promptly may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of Warning Letters regarding devices so that they may take this information into account when considering the award of contracts.
You should notify this office within fifteen working days from 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. 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.
Please send your reply to the Food and Drug Administration, Attention: Mark E. Parmon, Compliance Officer, Cincinnati District, 6751 Steger Drive, Cincinnati, OH 45237. If you have questions regarding any issue in this letter, please contact Mr. Parmon at (513) 679-2700, Ext. 2162.
Standard Textile Co., Inc. - Close Out Letter 6/24/14