- Delivery Method:
- United Parcel Service
- Medical Devices
Recipient NameJoshua (nmi) Gloria
Recipient TitlePlant Manager
- American Contract Systems, Inc.
7702 Parnell Street
Houston, TX 77021-6009
- Issuing Office:
- Office of Medical Device and Radiological Health Division 3 West
Dear Mr. Gloria:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, American Contract Systems, Inc., located at 7702 Parnell Street, Houston, TX, from September 9 through October 4, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer and contract sterilizer of various surgical trays / kits for hospital use. 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.
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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to adequately validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). During the inspection, we observed that your sterilization operations have not been adequately validated to demonstrate that all component materials, sizes, solutions, types, etc., can undergo and withstand your (b)(4) sterilization process and method. For example:
• Your firm’s Process Challenge Packs (PCPs) used in sterilization validation were not representative of your facility’s routinely sterilized components in each product family. There is no documented evidence that component materials you sterilize, such as PVP solution, catheter, stopcock, band bag, suction tubing, gowns, etc., were represented based on worst-case components by product families in your most recent sterilization validation summary report (VSR-TX-003) dated July 2017. Instead, your PCP device components were selected by (b)(4). The component materials in your PCPs for (b)(4), and (b)(4) sterilization bags did not include component materials routinely sterilized at your facility.
• Your firm’s highest volume component materials such as sponge bowl, med cup, and syringe were not represented in the sterilization bags as worst-case challenge packs, although your sterilization validation report selection criteria for material sample chosen is based on (b)(4). In addition, the process control devices used for (b)(4), and (b)(4) sterilization bags are (b)(4) than the surgical trays validated and identified in the device master record (DMR). There is no data to support your firm’s selection of worst-case components used in the Process Challenge Packs.
• Your July 2017 sterilization validation report (VSR-TX-003) noted that (b)(4) testing were performed using (b)(4) sized sterilization bags only. Your firm uses (b)(4), and (b)(4) sterilization bags during routine processing. No (b)(4) testing were performed on the (b)(4) and (b)(4) sized sterilization bags during validation. Additionally, the method of determining (b)(4) is not documented in the Sterilization Validation Protocol (SV-01, Rev 16, 12/4/16).
• Your Biological Indicators (BI’s) and Process Challenge Devices (PCD’s) were not placed inside assembled surgical trays to determine sterility effectiveness or challenge penetration of (b)(4) into assembled finished products. The PCD’s containing the BI’s is sealed in (b)(4) and placed within each of the test packs inside the sealed sterilization bags but external to the wrapped process challenge packs. There is no supporting documentation to show your firm has evaluated the resistance of the BI’s in the PCD’s.
• As per your sterilization validation protocol (SV-01), six product families were identified: 1) Woven goods – cotton; 2) Woven goods – natural or synthetic fibers, excluding cotton; 3) Non-woven goods – synthetic fibers; 4) Rigid plastics – thermoplastic, plastic; 5) Flexible plastics – silicone, rubber, plastic; and 6) Metals – generally surgical instruments. However, your validation failed to include woven goods and metals in its latest July 2017 sterilization validation report (VSR-TX-003) and continues to sterilize metals (such as scalpels) in the surgical convenience kits.
• Your firm assembles and sterilizes (b)(4), surgical trays; however, only one (1) out of (b)(4) surgical trays were included in your process control devices analyzed during the sterilization validation completed on July 2017.
We did not receive your firm’s response to determine if corrections and/or corrective actions have been implemented to address this violation. In response to this Warning Letter, you should provide your validation documents to ensure that all components currently being sterilized have supporting data to support their sterility claims. You should also address any specific steps you are taking to address products that may require additional remediation.
2. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example:
• Your firm has not established critical sterilization process parameters after a process validation, and there are no sterilization process parameters to be monitored and controlled for your (b)(4) process. Your firm’s Process Validation Procedure (PV-01, dated July 2017) requires your protocol to include “success criteria” as a list of operating parameters for evaluation. However, process parameters, such as (b)(4), used to monitor and control (b)(4) sterilization have not been evaluated during the sterilization validation (VSR-TX-003) conducted in July 2017.
• Your firm’s Process Validation Procedure (PV-01) does not identify the frequency for validating and revalidating manufacturing processes, such as (b)(4). Your validation records do not show these processes have been evaluated with any uniformity proportionate with risk it poses to the finished device.
• During the inspection, we observed that six (6) out of twelve (12) complaints reported between 2017 – 2019 were related to foreign matters (bugs) on the inside of sealed sterilized bags, one causing delayed surgery. Your Process Validation Procedure (PV-01) does not require the manufacturing process (Controlled Environment Cleanliness) in your raw material packaging area to be validated. The surgical packs are assembled, packaged, and prepared for sterilization at the firm, as well as stored in your warehouse area before being packaged for (b)(4) sterilization. There is no indication that your raw material packaging area is listed as a controlled environmental room.
We did not receive your firm’s response to determine if corrections and/or corrective actions have been implemented to address this violation. In response to this Warning Letter, you should provide evidence, based on a retrospective review, that all lots distributed by your firm have met the process parameters that were prescribed by your firm, as well as an immediate plan for how you will be monitoring these parameters in the future.
3. Failure to document the review and evaluation of a process performed in response to changes or process deviations, as required by 21 CFR 820.75(c). According to your firm’s Process Validation Procedure (PV-01), automated processes and software systems that control manufacturing operations or quality system require validation; it also requires evaluation of process or performance changes or deviations for revalidation. You firm did not revalidate several process changes that met criteria for revalidation. For example:
• Your firm’s (b)(4) software was updated from Rev. 3.004 to 3.005, per your CR-14 procedure, for changes associated with (b)(4). The addition, the (b)(4) was added to allow operator to change a critical operating parameter, (b)(4), from (b)(4) to (b)(4).
• Your (b)(4) maintenance log (dated 9/6/2019, equipment #(b)(4) Sterilizer) documented an issue with (b)(4). The (b)(4) was increased from (b)(4) to (b)(4) with no justification for the change.
• Your sterilization operating parameters were changed per your Design Change Requests for changes associated with (b)(4) process parameters ((b)(4)), without documented evidence that revalidation was conducted after these process changes. These changes were repeated due to lack of verification to assure previous changes did not affect the equipment ability to operate as intended.
We did not receive your firm’s response to determine if corrections and/or corrective actions have been implemented to address this violation. In response to this Warning Letter, you should provide evidence to demonstrate review and evaluation of software and process changes and/or deviations are adequately documented and revalidated where appropriate.
4. Failure to adequately validate computer software used as part of production for its intended use according to an established protocol, as required by 21 CFR 820.70(i). During the inspection, we observed your firm’s (b)(4) software system has not been fully validated per your Process Validation Procedure (PV-01). There was no protocol specific method used to document acceptance criteria and how the validation will be completed in your Software and Systems Validation Protocol (b)(4). For example:
• During our review, we observed (b)(4) software design changes were implemented from 08/1/11 to 4/5/19, with changes affecting critical process parameters such as (b)(4). There is no documented evidence the design changes were verified and/or validated prior to implementation. Also, there is no evidence that (b)(4) testing was done after the implementation of each software code changes.
• Your firm’s (b)(4) software does not display error codes to the operators when process parameters are not met. Software changes (CR-04, CR-06, and CR-08) were requested to show visible error codes when the (b)(4) process parameters were not within specification.
• There is no documented evidence that software (b)(4) testing and/or (b)(4) testing have been conducted for your firm’s (b)(4) Sterilization units ((b)(4)).
We did not receive your firm’s response to determine if corrections and/or corrective actions have been implemented to address this violation. In response to this Warning Letter, you should provide evidence to demonstrate the software changes have been validated before approval and issuance. Please describe how your firm will ensure any future changes will comply with the requirements of 21 CFR 820.70(i).
5. Failure to adequately maintain device master records, as required by 21 CFR 820.181. For example:
• During our review of your device master records (DMR), critical component specifications for sterilization processing activities were not identified for your top five (5) selling (b)(4) sterilized surgical trays. For example:
o Three (3) out of five (5) (b)(4) sterilized surgical trays are processed using (b)(4) that have not been validated: batch process #’s (b)(4)
o Two (2) out of five (5) (b)(4) sterilized by firm’s (b)(4) process have not been validated: batch process #’s (b)(4)
• Your firm’s process parameters were not established for all sterilization processing types (i.e. (b)(4)) sterilized at your firm. The production process specifications are not maintained in the DMR. For example:
o We reviewed your records associated with the sterilization of lot #190991 comprised of surgical tray #(b)(4). Your records indicate that this (b)(4) was placed into an (b)(4) sterilization bag, however, the validation report documents that only (b)(4) sterilization bag was tested. According to your Sterilization Validation Protocol (SV-01), the (b)(4) within (b)(4) sterilization bags is identified as a “Batch Process”. There was no explanation to why the (b)(4) sterilization bag was used instead of the (b)(4) sterilization bag that was validated.
• In addition, your DMR did not include requirements and specifications for all equipment used, software specifications, production process specifications, quality system procedure, packaging, and labeling, or reference to the location of this information.
We did not receive your firm’s response to determine if corrections and/or corrective actions have been implemented to address this violation. In response to this Warning Letter, we would expect that you will be revising your device master records (DMR) accordingly to ensure that they include, or refer to the locations of, all device specifications, component specifications, production process, specifications, quality assurance procedures, packaging and labeling specification, including sterilization bag size, as required by 21 CFR 820.181.
This is a repeat observation from the previous FDA inspection, dated March 15 – 23, 2011.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent via e-mail to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at ORADevices3FirmResponse@fda.hhs.gov. Please identify your response with CMS case #595573 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer Charles J. Chacko at 214-253-4939, or via email at email@example.com.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulation administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health Division 3 West