Inspections, Compliance, Enforcement, and Criminal Investigations
Sgarlato Laboratories 27-Aug-08
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
August 27, 2008
Thomas Sgarlato, DPM
President and CEO
1975 Hamilton Avenue, Suite 38
San Jose, CA 95125
Dear Dr. Sgarlato:
During an inspection of your firm located in San Jose, CA on January 8, 2008 through January 22, 2008, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sgarlato Pain Free Pumps, 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 establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b).
For example, your firm's [redacted] Inspection Document [redacted] states in Step [redacted] page [redacted] of [redacted] will perform the [redacted] per Operational procedure [redacted] will perform inspection and testing required and record the results on [redacted]
According to a document provided to the investigator, your firm had a total of [redacted] Pain Pumps in stock in a total of [redacted] lots [redacted]. Your firm was asked for the Receiving Inspection Record [redacted] for each lot; however your firm was unable to provide any receiving inspection documentation for Lots [redacted]. Your firm did provide documentation for Lots [redacted] and however for lot [redacted], the receiving inspection record states "Did not test these pumps, had to fill order". Additionally, on a receiving inspection record for a combination of lots [redacted] and [redacted] the operator stated "Did not test these pumps per [redacted]".
Your firm did not perform [redacted] testing for at least [redacted] lots of pain free pumps representing [redacted] Pain Free Pumps, Model PF100-2.0. This represent a serious deficiency in Receiving & Acceptance; and indicates your firm introduced untested pumps into interstate distribution.
2. Failure to establish and maintain procedures to ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed, as required by 21 CFR 820.160(a).
For example, your firm shipped a Pain Free Pump kit, Lot 60772460, with the expiration date on the label "blackened" out with a marker. The expiration date of two years for this pump, p/n 7S1530, was verified with a certificate of compliance provided by the supplier, [redacted] Proof of shipping expired lot 60772460 was demonstrated with [redacted] showing the Pain Free Pump kit was sold to a [redacted] in [redacted]. This invoice also contained the [redacted] tracking number and a delivery confirmation from the [redacted] website with the same tracking number was provided. Additionally, Thomas E. Sgarlato, President and CEO of Sgarlito Laboratories [redacted]
3. Failure to establish and maintain procedures to control labeling activities to ensure labeling is not released for storage or used until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR, as required by 21 CFR 820.120(b).
For example, according to labels attached to lot 60772460, the manufacturing date is placed next to a symbol of a factory and is shown to be "2010-02", the expiration date is placed next to a symbol of an hourglass and is shown to be "2014-04". The meaning of the symbol of the factory is described in the product labeling as "manufacturing date" and the hourglass is described as "expiration date". These labels were affixed over the manufacturer's labeling. Your firm was unable to provide justification for the extension of the expiration date.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).
For example, your firm received a complaint for a leaking Pain Free Pump. The complaint form contains a section with this statement [redacted]. The [redacted] was checked off on this page, however on your firm associated [redacted], Step 9 [redacted] the operator hand-wrote in "When patient was taken to recovery-pump started leaking". The information provided by the complainant regarding the patient's circumstances is not sufficient to determine if MDR reporting was required.
5. Failure to establish and maintain procedures implementing corrective and preventive action, as required by 21 CFR 820.70(a)
For example, your firm initiated a "Corrective Action Request" in response to a 2006 FDA inspection which resulted in an observation regarding training of sales staff in complaint handling. Your firm initiated this Corrective Action Request on [redacted] however as of January, 2008, no investigation into the cause of the nonconforming process had been performed and no action to correct and prevent recurrence of this nonconforming process had been identified.
6. Failure to establish and maintain procedures identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented, as required by 21 CFR 820.25(b).
For example, no evidence was shown that the staff responsible for complaint handling have been trained in bur firm's "Technical Calls and Customer Complaint Handling - Document [redacted] procedure. The investigator asked your firm for documentation of the training undergone by the complaint handling staff and no documentation was presented by Dr. Sgarlato.
7. Failure to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22
For example, according to your firm's procedure "Internal Quality Audits Document [redacted]. Step [redacted] "Each main activity comprising the Quality System is audited [redacted]. Your firm was unable to provide documentation of quality audits taking place for the past two years.
8. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).
For example, according to your firm's procedure "Management Review, Document [redacted], Step [redacted] "The CEO will conduct a review of the status of the quality system to ensure that it continues to meet the requirements of [redacted] and the company's quality goals. That review will be performed [redacted]. Your firm was unable to provide documentation of a management review, taking place in 2007. The most recent management review occurred, in 2006.
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 being initiated by the Food and Drug Administration 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 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.
Your response should be sent to: Sergio Chavez, Compliance Officer, United States Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions about the content of this letter please contact: Sergio Chavez at (510) 337-6886.
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.
Barbara J. Cassens
San Francisco District