Inspections, Compliance, Enforcement, and Criminal Investigations
Customed, Inc 9/11/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|466 Fernandez Juncos Avenue|
San Juan, Puerto Rico, 00901
September 11, 2009
Return Receipt Requested
Mr. Felix B. Santos
Owner and President
Calle Igualdad Final #7
Fajardo, P.R. 00738
Dear Mr. Santos:
During an inspection of your firm located in Calle Igualdad #7 Final, Fajardo, Puerto Rico from March 31, 2009 through May 13, 2009, an Investigator from the United States Food & Drug Administration (FDA) determined that your firm manufactures convenience kits including surgical trays and packs, nursing kits, and baby care kits, among others. 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.
The 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 Regulation (QSR) found under Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received a response dated June 8, 2009, and a follow-up response, dated July 3, 2009, from Mr. James P. Weisse, General Manager, in response to observations included in Form FDA 483, List of Inspectional Observations, issued to your firm on May 13,2009. We address your response below, in relation to the noted violations.
These violations include, but are not limited to, the following:
1. Failure to validate and approve a process whose results cannot be fully verified by subsequent inspection and test as required by 21 CFR 820.75(a).
Your firm failed to demonstrate that after aeration convenience kits exposed to ETO sterilization and re-sterilization cycles render acceptable ethylene oxide (EO) and ethylene chlorohydrins (ECH) residual levels and prior to commercial distribution, as follows:
Inspectional evidence showed that the residual limit results were reported as a composite of
samples of devices within the convenience kits. The current (b)(4) does not provide for the composite-sample-test of multi-device systems as your convenience kits. The mentioned standard provides information on multi-device systems as follows:
a) Under 4 Requirements,(b)(4) Special situations "For multi-device systems the limits
shall apply to each individual patient-contact device".
b) Under 4 Requirements,(b)(4) Product sampling "When selecting samples, attention
shall be given to the many factors described in Annex (b)(4)".
c) Under 5 Product release,(b)(4) General "If sufficient experimental data on residue
(b)(4) are available, it may be possible to group devices for quality assurance testing based on similarity of materials, manufacturing processes and use
(see Annex (b)(4)".
d) Under Annex (b)(4) "If this is a multi-device system, the limits apply to each
individual patient-contact device".
e) Under Annex (b)(4) Device kits and trays "Initially determine residues for each
EO-and ECH-absorbing patient-contact device in kits and trays, and establish the
worst-case device or devices. Additional data can be collected using such worst cases.
Document the rational for the decision".
f) Under Annex (b)(4) Factors influencing product residual (b)(4) General overview "An
understanding of EO kinetic may make it possible to address a family of like devices
through the analysis of a "worst-case" representative".
During the inspection your firm did not provide evidence that your current composite-sampling testing procedure was based on the parameters described for the understanding of the EO kinetics such as material composition, packaging, EO sterilization cycle(s), aeration, sample retrieval, similarities in size and use, water content, and exposure to environmental conditions. The practice of composite sample-test may masquerade non-conforming residue limit results from individual device or devices within the convenience kits. Specifically, under Annex (b)(4) letter e above) it is established that for kits and trays, residues of EO and ECH are to initially be determined to identify the worst case device or devices within the subject convenience kits. Once that device or devices are identified then those are to be collected and tested for EO and ECH residual limits as representing the specific convenience kit.
We evaluated your response and found it to be adequate to address the aforesaid observation under your CAPA 09-0004. Nonetheless, your marketed products are to be considered adulterated until submission of your assessment of the protocol executed demonstrates that your convenience kit products are in conformance with current standards. At this time we have not received your findings and/or closure of your CAPA 09-0004. Therefore, we are concerned with your marketed products since at this time there is no assurance that safe ETO residual levels were in conformance with current standards prior to release and distribution as discussed in this letter. In your response to this letter, provide your assessment of the protocol results and explain your intention regarding your sterilized ETO products on the market in the event your assessment of the protocol evidence nonconformance with current ETO residual levels.
2. Failure to evaluate and select potential contractors on the basis of their ability to meet specified requirements as required by 21 CFR 820.50 (a) (1).
Specifically, your procedures to approve contract providers and external services failed to thoroughly assess the contract laboratory capability to perform the ETO residual test. The test methods used by the contract laboratory testing your products for ETO residuals refer to (b)(4) As discussed on item number 1 of this letter, composite sample-test of multi-devices systems is not contemplated within the referred standard. However, your firm has been accepting ETO residuals reported as a composite of samples from the devices within the kits. Moreover, no documentation was provided during the inspection to demonstrate that your firm assessed the capability of the laboratory contracted to conduct such analysis in conformance with the subject standards.
We reviewed your response to this observation as it applies to SOP (b)(4) Revision (b)(4) "Monitoring of Ethylene Oxide and Ethylene Chlorohydrins Residuals" and found that if properly implemented, the SOP appears to adequately address the observation in relation to the ETO residual test. However, you did not describe any corrective actions addressing your SOP (b)(4) Revision New "APPROVED CONTRACT PROVIDERS AND EXTERNAL SERVICES".
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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.
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 violations, from occurring again. Include documentation of the 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 dates, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Maridalia Torres, District Director. If you have any questions about the content of this letter please contact: Wanda J. Torres, Acting Compliance Officer.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. 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 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 violations, and take prompt actions to correct them and bring your products into compliance.
Maridalia Torres Irizarry
San Juan District Office