Augusta Medical Systems, LLC 1/12/12
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161
FAX: 404-253-1202
January 12, 2012
VIA UPS
Michael Osbon, CEO
Augusta Medical Systems, LLC
1025 Broad Street
Augusta, GA 30901
WARNING LETTER
(12-ATL-07)
Dear Mr. Osbon:
During an inspection of your firm conducted at 1025 Broad Street in Augusta, Ga on September, 19 - 23, 2011, an investigator from the U.S. Food and Drug Administration (FDA) determined that your firm manufactures external penile rigidity devices. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 321(h)] in that 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) regulations found at Title 21 of the Code of Federal Regulations (CFR) Part 820 (CFR Part 820).
A Form FDA 483, Inspectional Observations, was issued to you at the close of the inspection (copy enclosed). We received a response from you dated October 12, 2011, concerning our investigator's observations identified on the FDA 483. We address this response below, in relation to each of the noted violations. The violations documented on the FDA 483 issued include, but are not limited to, the following:
1. Failure to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by CFR Part 820.80 (d). Specifically, during our inspection it was determined that the Pump Head Final Inspection Sheets for the following lots of Response II and Touch II devices photocopied from an unknown production record: lot #(b)(4) lot #(b)(4) lot #(b)(4) lot #(b)(4) lot #(b)(4) lot #(b)(4) lot #(b)(4) lot #(b)(4). As a result, the device history records for these lots do not ensure that each of these finished devices met the acceptance criteria identified in your procedure titled "Final Inspection for Battery and Manual Pump Heads".
We have reviewed your response and request further information for the following in order for us to evaluate your corrective actions: 1) additional documentation identifying the final inspection did occur as indicated in your response letter; 2) identify the types of ICRs used in your hazard analysis; 3) what steps your firm has taken to identify which lots were effected by the use of the photocopied form and evidence that these lots met the finished device acceptance criteria.
2. Failure to document that all personnel are trained to adequately perform their assigned responsibilities, as required by CFR Part 820.25 (b). Specifically, no documentation was provided which demonstrated that manufacturing technicians or customer service personnel received training for their assigned duties.
We have reviewed your response and find it inadequate as no documentation was provided demonstrating that employees have been trained for their assigned duties.
You should take prompt action to correct the violations addressed in this letter and noted on the FDA 483 issued at the closeout of the inspection. Failure to promptly correct these violations 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. Also, 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 ate 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 violations, or similar ones, from occurring again. Include documentation of corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If 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.
This letter is not intended to be an all-inclusive list of the violations at your firm. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the form FDA 483, Inspectional Observations, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your
products into compliance.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Derek Price, Compliance Officer; 60 Eighth Street NE; Atlanta, GA 30309. If you have any questions, please contact Mr. Price at 404-253-2277.
Sincerely,
/S/
John R. Gridley
District Director
Atlanta District Office
