Inspections, Compliance, Enforcement, and Criminal Investigations
Shoney Scientific India
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
JAN 20, 2011
Via United Parcel Service
Mr. Rajesh R. Shoney
Chief Executive Officer
Shoney Scientific India
A30/B, Industrial Estate, Thattanchavady
Dear Mr. Shoney:
During an inspection of your firm located in Pondicherry, India from August 17, 2010 through August 20, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Biopsy Punches, Dermal Curettes, Liposuction Cannulas, OS Dilators, Uterine Sounds, Endocervical Curettes, Nasal Speculums, Tongue Cleaners, Elbow Immobilizers, and Wrist Restrainers. 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 are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example: your firm currently uses a Horizontal Band Sealing Machine, Equipment #(b)(4), to heat seal sterile packaging for Disposable Biopsy Punches; however, the heat sealing process has not been validated.
2. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example: your final device acceptance procedures fail to require that the ETO Sterilization Certification for the biopsy punch products be reviewed prior to release for distribution. Sterilization Lot # (b)(4), dated July 19, 2010, and Lot # (b)(4), dated June 11, 2010, are examples.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)). Also, U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: Alan Gion, Acting Branch Chief, General Surgery Devices Branch, Division of Enforcement A, WO66-3520, at the address on this letterhead. If you have any questions about the content of this letter please contact: (b)(5) at 301-796-(b)(5) or fax at 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems.
You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and