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  1. Warning Letters

WARNING LETTER

JAS Diagnostics/Drew Scientific, Inc. MARCS-CMS 634208 —

Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Jean Felix LaCroix
Recipient Title
Owner/CEO
JAS Diagnostics/Drew Scientific, Inc.

14100 NW 57th Ct
Miami Lakes, FL 33014-3107
United States

Flacroix@JASdrew.com
Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS# (634208)

August 16, 2022

Dear Mr. LaCroix:

During an inspection of your firm located at 14100 NW 57th Ct, Miami Lakes, FL 33014-3107 on April 15, 2022 through April 28, 2022, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a medical device manufacturer and repackager/relabeler of in vitro diagnostic (IVD) Chemistry, Hematology Reagents. 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.

We received responses from Mr. Felix LaCroix, CEO dated May 13, 2022 and June 10, 2022 concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to the following:

1. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). Specifically, you have not adequately implemented your complaint handling procedure titled “Customer Complaint Handling”, Doc. # EQA 6.2, in that complaints were not adequately documented, investigated, and evaluated for Medical Device Reportable (MDR) events.
For example,

A. Complaints received alleging deficiencies to damaged products during shipping are not documented, evaluated, and investigated according to your complaint handling procedure “Customer Complaint Handling”, Doc. # EQA 6.2. Your firm received 25 complaints in 2021-2022 associated with products arriving damaged, leaking, or controls out-of-temperature which were documented in a spreadsheet log titled “Customer Complaint Log”. Nineteen (19) of these complaints were associated with reagents and controls for your Drew3 analyzer, while 6 complaints were associated to the veterinary (b)(4) analyzer. Only one of these complaints, C21-04-01, was documented as per EQA 6.3, evaluated for MDR, and investigated. Further, your firm did not maintain records for these “non-technical” complaints for 2020.

B. Your complaint handling procedure Doc. # EQA 6.2 states that instrument complaints will be handled according to procedure “Instrument Service and Complaints”, Doc. # IESD 1.0. Instrument complaints are entered into (b)(4) as a “case”. Your firm does not maintain adequate documentation of communications received regarding the performance of the Drew3 analyzer instruments that include an evaluation to determine whether an investigation is necessary, and the evaluation of potential adverse events associated with the reported event. 119 of 277 (b)(4) cases entered from January 2020 - April 2022 were associated to troubleshooting and service activities for the Drew3 Analyzer system. We reviewed 52 cases associated to the Drew3 Analyzer and found 48 did not have the MDR event evaluation, and 50 did not have the results of the investigation. Of the 4 reports with an MDR evaluation, two were not reviewed and signed off by Quality Assurance as per “Customer Complaint Handling”, Doc. # EQA 6.2.

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response indicates that you plan to (b)(4). You also stated that (b)(4). The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

2. Failure to adequately establish CAPA procedures as required by 21 CFR 820.100(a). Specifically,

A. The investigations of failures were not extended to evaluate the adequacy of the root cause analysis process and to identify other products potentially affected by the root cause, and CAPAs were closed without identifying root cause or completing actions. For example,

i. CAPA 21-002 was initiated on 09/19/2021 to investigate multiple complaints from different customers reporting boxes of products arriving broken/damaged/wet, leaking bottles, and kits that appeared to have been hastily put together during April – July 2021. Your investigation root cause stated (b)(4) mishandled the packages during transit, without an adequate investigation to determine this conclusion. As a result, no corrective actions were implemented, and the Verification of Effectiveness (VOE) failed as additional complaints for damaged and leaking products were received from November 2021 - February 2022. Furthermore, your firm failed to extend the investigation to determine if the design change of the caps for the Enzymatic Cleaner and Lytic Reagent, its design change validation, and its process validation, were adequate. Six of the complaints received from 06/8/2021 – 07/14/2021 were associated to Drew3 Pac Reagent Kit, Lots #(b)(4) and #(b)(4), which were produced with the new caps for these two reagents. No further actions have been taken for this CAPA after it failed VOE and the CAPA has remained open without further actions since 11/24/2021.

ii. CAPA 21-001 was initiated on 04/16/2021 to investigate complaints related to high background counts on various lots of FS-Pak Test Kits for your veterinary hematology device (b)(4). Your root cause for CAPA 21-001 indicated that the laboratory analysis identified presence of particles in the diluent of (b)(4), (b)(4), and (b)(4) composition which your firm attributed to the set parameters of the (b)(4) induction sealer which produced excessive heat and melting of the polymer layer of the FS- Pak Test Kits caps. However, these settings had been validated and in use since (b)(4) under validation protocol # VP-015-005 and had passed your tests. Validation protocol #VP-015- 005 also validated this (b)(4) induction sealer for the Drew3-Pac 5L Diluent Reagent. Our review of the validation #VP-015-005 identified inadequate process validation to test the seal integrity. This CAPA 21-001 failed to extend the investigation to the Drew3-Pac 5L Diluent to determine if the (b)(4) induction sealing parameters for the Drew3-Pac 5L Diluent bottles also affected this product and may have also contributed to the particles that were found in the diluent that were attributed to the Recall # Z-1576-2016 for high background counts as your previous CAPA 16-006 did not characterize the material of the particles found in those bottles. This CAPA remains open.

iii. CAPA 19-010 was initiated on (b)(4) due to two complaints received for Alanine Aminotransferase (ALT), Lot #(b)(4), reporting ABSLim error. The CAPA found the ABSLim error appeared to be related to the decrease of the reagent absorbance but could not identify the reason for the absorbance not reaching specifications at 12 months expiration. Your firm closed this CAPA 19-010 within two months without a root cause on 07/26/2019 with a recommendation to monitor the performance of the reagent by (b)(4). A new CAPA 19-012 was opened two months later on 09/13/2019 due to the failed VOE of CAPA 19-010 to continue to investigate the ABSLim error and decrease of absorbance of the Alanine Aminotransferase (ALT). However, this CAPA 19-012 was also closed on 11/30/2020 without completion of an investigation. Further, no adequate evaluation or actions were conducted to address the impacted lots of products in commercial distribution.

iv. CAPA 19-011 was initiated on (b)(4) due to corrective actions that failed Verification of Effectiveness to address an internal audit nonconformance ANR#16-005. This CAPA was closed on 11/19/2021 citing those corrective actions had not been completed as the employees responsible for Facilities & Maintenance and implementation of the CAPA were no longer with the company. It also stated that a new Action Item will be added to your firm’s Quality Plan, Doc. # QP-2020-01, Rev. 2, to review the structure of your departments and ensure all managers have trained employees to act as back-up to continue to conduct activities when an employee is absent. We found continued deficiencies in Facilities & Maintenance in that the current Equipment Inspection Log for the (b)(4) system continues to demonstrate lack of good documentation practices and the records for the (b)(4) system monitoring showed (b)(4) was not sampled and tested from 02/25/2019 through 09/21/2021 and from 02/10/2022 through 04/04/2022 due to absence of personnel.

CAPA deficiencies were previously communicated to your firm in our 2014 FDA 483, 2019 FDA 483, and 2020 Untitled Letter.

B. You are not adequately trending quality indicators such as complaints, services, nonconformances, laboratory out-of-specification results, and manufacturing rejection rates, using appropriate statistical methodology where necessary to detect recurring quality problems. For example, your current trending report only trends the number of services and preventive maintenance performed and does not include cases of troubleshooting. Your review also fails to trend by product, issue, device identification number, or other factors as needed to detect recurring problems. No other quality data trending is performed.

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response indicates that you plan to (b)(4). It also states your intention to (b)(4) and describes that you gathered data for complaints, services, non-conformances, out-of-specification lab results, manufacturing deviations, troubleshooting, and preventive maintenance for review and trend analysis. The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

3. Failure to adequately establish a process whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75(a). Specifically, you have not adequately implemented your process validation procedure, “Validation Procedure”, Doc # EMF 1.0. For example,

A. Your firm has no documented evidence of the process validation for the mixing, filling, and capping of the Drew3-Pac Diluent and Enzymatic Cleaner reagents and the mixing validation for the Lysing reagent currently manufactured at your facility which compose the Drew3-Pac kit for use with your Drew3 Analyzer. Further, your firm has not completed the process validations for the JAS Chemistry IVDs including (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4).

B. Your firm did not adequately conduct the process validation for the new (b)(4) induction sealer used for the Drew3-Pac Diluent 5L bottle caps, Validation # VP-021-007. The following deficiencies were noted:

i. The Operational Qualification (OP) “Heat Seal Integrity Test” consisted of only visual inspection of the seal and visual inspection for leaks of (b)(4) bottles filled with (b)(4). There was no justification for the use of (b)(4) and for the sample size to be representative of a production lot of Drew3-Pac Diluent which consists of (b)(4) bottles.
ii. The Product Performance Qualification (PPQ) states it was conducted with only one production lot of Drew3-Pac Diluent, Lot (b)(4). The Device History Record (DHR) for Lot (b)(4) does not indicate that the diluent bottles were sealed with your new magnetic induction sealer being validated, instead, the DHR for Lot (b)(4) indicates the bottle caps were sealed using your previous (b)(4) heat sealer, ID #(b)(4).
iii. The conveyor belt speed parameter was set to 4.8-5, but your OQ states it was set and run at 5.2.

C. Your firm did not adequately conduct the process validation for the (b)(4) heat induction sealer, ID #(b)(4), Validation # (b)(4), used for the D3 Diluent 5L bottles until Lot #(b)(4), last filled on 09/24/2021. The “heat seal integrity test” consisted of only visual inspection of the seal and visual inspection for leaks of (b)(4) bottles. There was no justification for the sample size of (b)(4) bottles to be representative of a production lot of Drew3-Pac Diluent which consists of (b)(4) bottles. Your visual inspection of the heat seal integrity test indicated that the (b)(4) bottles passed at sealer parameters of 100% power and (b)(4). However, a documented deviation indicated that Lot #(b)(4) and the following two production lots were found to have a small number of caps/seals leaking which was not evident initially. As a result, your firm adjusted the sealer time from (b)(4) to (b)(4) but repeated the same visual test again on only (b)(4) additional bottles.

D. Your firm has not conducted validation of the off-the-shelf (b)(4) software used to manage warehouse activities (in-coming, inventory, status, distribution), BOM preparation, and service orders to verify the software meets your needs and intended uses.

E. You have not validated the microbial test method performed on the (b)(4) system using the (b)(4).

Process validation deficiencies were previously communicated to your firm in our 2014 FDA 483, 2019 FDA 483, and 2020 Untitled Letter.

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response states your intent to review and revise your validation procedure and includes a Retrospective Validation Report for your DREW3-PAC. It also indicates that you are planning to create a validation protocol for your (b)(4) software and are gathering documentation and data to amend the validation summary reports for your (b)(4) induction sealer and (b)(4) heat induction sealer. You also promised to perform an in-house verification for the (b)(4) test method. The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

4. Failure to establish design control procedures as required by 21 CFR 820.30(a). Specifically, you have not adequately implemented your design control procedure “Design Controls”, Doc. # ER&D 4.1 in that your firm has not adequately completed implementation of corrections to observations cited during previous inspections associated to Design History File (DHF), design reviews, risk assessment, and shipping validation. For example,

A. Your firm has not adequately maintained a Design History File (DHF) for the Drew3 Analyzer system that includes design inputs, design outputs, design reviews, design verification, design validation, and design changes for the system which includes the analyzer, controls, calibrators, and reagents. Your firm conducted a retroactive review of a DHF as correction to previous observations. However, the file presented to us was a DHF exclusively for the Drew3-Pac kit reagents (Diluent, Enzymatic Cleaner, Lysing reagents). Furthermore, we found the retrospective review was inadequate in that the DHF did not include the design input and design output specifications for product packaging including the reagent bottles, caps, and packaging components as well as no documentation of the design change evaluation to the bottle caps of the Diluent, Lysing reagent, and Enzymatic Cleaner and their new specifications.

B. The design change validation for the new caps of the 5L Diluent, Doc. #VP-020-001, and validation for the new caps for the Lysing Reagent and Enzymatic Cleaner bottles, Doc. #VP- 021-001, were inadequate:

i. Doc. #VP-021-001: The validation did not evaluate the impact to the capper, magnetic induction sealer, and torque requirements for the new caps which had different specifications from the previous caps, there is no rationale for the sampling size of (b)(4) bottles from a lot of (b)(4) bottles, and the leak test consisting of visual examination and no defined pressure applied is inadequate. Your firm received five complaints for product damaged and/or leaking on D3-Pac Reagent kits Lot #(b)(4) and one complaint for Lot #(b)(4) between 06/08/2021 and 07/14/2021 after implementation of the new caps.

ii. Doc. #VP-020-001: The validation did not evaluate the impact to the capper, heat induction sealer, and torque requirements, there is no rationale for the sampling size of (b)(4) from a lot of (b)(4) bottles, and the leak test consisting of visual examination and no defined pressure applied is inadequate.

C. Your firm has not conducted shipping validation for the EX-TROL controls and EX-CAL calibrators that require (b)(4)°C storage. Your firm documented at least five complaints for “hot” or “damaged” controls received between March 2021 – September 2021.

D. Your firm has not evaluated the instructions on the Operator’s Manual for the dilution of the sodium hypochlorite. For example, according to the current Operator’s Manual, M- Drew3-US- OP, Rev. 1.07, September 2019, the user is to perform this cleaning per scheduled maintenance recommendation (monthly or more frequent if processing more than 50 samples per day) or as necessary when there is excessive rejection (*, R-CL, W-CL) for one measured parameter using a Sodium Hypochlorite solution (bleach) at 12% in chloride. However, your firm identified that the bleach solution you use must be a particular grocery chain brand with 7.5% sodium hypochlorite further diluted to approximately 3% in chloride. We also identified complaints that required the use of 50% bleach solution and running the bleach cycle up to 3 times as part of the troubleshooting. Your firm has not validated the use of the Sodium Hypochlorite solution concentration and the frequency of use stated in the Operator’s Manual.

E. Your firm failed to adequately implement risk management procedure “Risk Management Process”, Doc. # EQA 4.2. Your complaint handling procedure Doc. # EQA 6.2 states that risk assessment must be performed in accordance with EQA 4.2 for each complaint to determine possible impact to safety, new hazards/hazardous situations, and/or increased risks from existing hazards. However, none of the complaints reviewed found this risk assessment is being performed for each complaint. Furthermore, we identified hazards noted in complaints that were not listed in your risk analysis files. For example, the risk analysis for the Drew3 analyzer, “Risk Analysis Project”, D3, Version 9, dated 12/22/2014, does not include the following hazardous situations:

i. Needle mis-positioning and possible needle plunging twice into the same chamber
ii. Sample needle leaking during sampling
iii. Counting chamber broken with reported problem with hemoglobin (HGB) count
iv. Pressure default errors

Design Control deficiencies were previously communicated to your firm in our 2009 FDA 483, 2014 FDA 483, 2019 FDA 483, and 2020 Untitled Letter.

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response states your intent to (b)(4). It also states that you plan to (b)(4). The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

5. Failure to adequately establish procedures for the control of product that does not conform to specified requirements as required by 21 CFR 820.30(a). Specifically, you have not adequately implemented your non-conforming product procedures. For example,

A. Your firm did not adequately implement “Nonconforming Material Control and Material Review Board Procedures”, Doc. # EQA 5.0. On 04/05/2022, we observed two pallets of 5L bottles, Lot (b)(4), used for the Drew3-Pac Diluent in your filling room labeled as “Do Not Use”. Your firm indicated that the bottles of these two pallets had been found to have defects including holes on the handles which caused leakage of the Diluent during the filling process. One pallet was received on (b)(4) and another on (b)(4). Your firm did not document this non-conformance as per EQA 5.0, failed to document an evaluation of the affected product lots filled with this lot of bottles, and failed to document the disposition of those filled bottles. The Device History Records (DHR) also had no record of this non-conformance.

B. Your firm is not adequately implementing the laboratory procedure “Out of Specification (OOS) Investigations”, Doc. # EQC 2.0, for documenting and investigating Out of Specification results obtained during quality testing of your products. For example,

EX-TROL Control Lot # (b)(4) (Low, Normal, and High) exhibited results out-of-range on various instruments during June 2021. Examples include the following:

i. 06/21/2021: (b)(4) in instrument serial numbers (b)(4), (b)(4) and (b)(4) in (b)(4)
ii. 06/23/2021: (b)(4) in instrument serial numbers (b)(4), (b)(4) and (b)(4)
iii. 06/28/2021: (b)(4) in instrument serial numbers (b)(4), (b)(4) and (b)(4)

Your laboratory was unable to provide information if any samples were processed on the above- mentioned days, possible reason for these failures observed for Control (b)(4) in three separate instruments on the same days, or any actions taken.

C. You are not adequately implementing your procedure “DREW3 Lysing Reagent Bulk Testing and Disposition”, Doc. # EQC 4.0. The low control (b)(4) exhibited inadequate readings during the quality control run performed prior to the Drew3-Pac Lysing Reagent Bulk (b)(4) sample on 06/09/2021 in instrument S/N (b)(4). However, this control (b)(4) was re-run and obtained a passing result which was included in the manufacturing record, but the out-of- specification result was not documented in the DHR.

D. You are not adequately implementing your procedure EQC 3.3 “Test and Disposition for DREW-3 PAC Reagents Kits” which states that sections 6.8.2 the Background (3 Diluents) and 6.8.3 Kit Recovery (Controls Low, Normal, and High, and 3 samples) do not meet acceptance criteria, the kit shall (b)(4) ((b)(4)) and recorded in a new FEQC 3.31 form. We observed this procedure not being adequately implemented in that there is no documentation for the following missing results or sequences of samples missing in between samples. For example,

Finished Drew3-Pac kits, Lot (b)(4):

i. Kit #1 is missing the results for Diluent #3, Control (b)(4), Control (b)(4), and sequence (b)(4) between Sample 1 and Sample 2 in instrument S/N (b)(4)
ii. Kit #2 is missing sequences 8240-8244 between Diluent 1 and Diluent 2 and sequences 8251-8252 between Sample 1 and Sample 2 in instrument S/N (b)(4)
iii. Kit #3 is missing sequences 10859-10860 between Diluent 1 and Diluent 2 and sequences (b)(4) and (b)(4) for Sample 1 in instrument S/N (b)(4)
iv. Kit #4 is missing the results of Diluent 2, Diluent 3, Controls L, N, H and sequence 27855 between Sample 2 and Sample 3 in instrument S/N (b)(4)
v. Kit #5 is missing sequences 42381-42384 between Sample 1 and Sample 2 in instrument S/N (b)(4)

Finished Drew3-Pac, Lot (b)(4):

i. Kit #1 is missing sequence 7602, 7604 and 7607 between Controls in instrument S/N (b)(4). The Quality Control Report for the Controls shows Control L (low) and Control N (normal) were out-of-range.

ii. Kit #2 is missing sequence 8621 between Diluent 1 and Diluent 2, sequence 8627 between Control Low and Sample 1 and sequence 8629 in between samples in instrument S/N (b)(4)

iii. Kit #3 is missing sequence 7020 between Control L and Sample 1, and sequence 7022 between Sample 1 and Sample 2 in instrument S/N (b)(4). The Quality Control Report for the controls shows Control L (low) was out-of-range.

iv. Kit #5 is missing sequence 28220 between Control N and Control H, and sequence 28222 between Control H and Sample 1, and sequence 28224 between Sample 1 and Sample 2 in instrument S/N (b)(4). The Quality Control Report for the controls shows Control L (low) and Control (normal) were out-of-range.

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response to the 483 regarding Lot (b)(4) states that you issued a SCAR to the supplier and are investigating/gathering all documentation regarding Lot “(b)(4)”. You also promised to investigate and document OOS results correctly and revise or amend all missing sequences or data listed in Observation 5D for the affected lots. The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

6. Failure to adequately establish procedures for acceptance as required by 21 CFR 820.80(a). Specifically, your firm is not adequately implementing incoming quality control procedure “Procedure for the Inspection, QC Verification, and Release of Hematology Controls”, Doc # EQC 16.0, to test and release new lots of Hematology Controls received at your facility. EQC 16.0 requires running each type of control (low, normal, high) three times using two hematology analyzers, however, your firm ran each type of control only once in two analyzers for Lot #(b)(4).

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response states your intent to conduct a deviation investigation for Lot #(b)(4) and provide justification. The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

7. Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Specifically,

A. You have not adequately implemented your supplier control procedure “Supplier/Service Provider Qualification Program”, Doc. # EQA 7.0. For example,

i. Your approved supplier list does not include the list of all your approved suppliers, contractors, and consultant(s) as per your procedure.

ii. You have not documented the evaluation of your quality consultant and your supplier that supplies your bleach used to service Drew3 Analyzers and as raw material for your Hema- Clenz.

iii. Your evaluation of your contract manufacturers is inadequate in that you have not ensured that your contract manufacturers have adequately validated their manufacturing process such as the injection molding process of the 5L diluent bottles.

iv. You did not ensure that appropriate corrective actions were taken by your supplier. For example, your firm issued a request via e-mail for investigation and corrective action to your supplier of your 5L bottles after bottles were found to have holes. This action was not documented as a Supplier Corrective Action Request (SCAR) as per your procedure. The contract manufacturer provided their Corrective Action Report, date completed 02/04/2021, with an inadequate investigation and indicated possible root cause due to the (b)(4). Their corrective action states that they would (b)(4). However, your firm did not ensure that the contract manufacturer of the bottles verified or validated this corrective action and adequately implemented this action. Your firm received another pallet of defective bottles of the same lot on 04/01/2021 after implementation of this correction.

B. Your supplier control procedure “Supplier/Service Provider Qualification Program”, Doc. # EQA 7.0, does not define when an on-site audit is necessary.

Purchasing Control deficiencies were previously communicated to your firm in our 2019 FDA 483 and 2020 Untitled Letter.

We reviewed your firm’s response but are unable to assess the adequacy of your response as the corrections are in progress. Your response states your intent to review and revise your supplier qualification procedure and reevaluate all suppliers to ensure they remain qualified. You also promised to revise your master vendor list. The adequacy of your response cannot be determined at this time. A follow-up inspection by FDA is necessary to verify compliance.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter 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.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Additionally, the following has also been noted about your firm and corrective actions should be addressed in your response:

8. On your webpage (https://www.drewscientific.com/d3) for the D3 hematology analyzer, in the “Performance” segment, under “Part Code” section, the following information about the instrumentation and its description are incorrect and should be removed.

Part CodeDescription
BAR-9000-2212280 Hematology analyzer with computer & barcode reader
BAR-9001-2212280 Hematology analyzer without computer & barcode reader

9. On the webpage (https://www.drewscientific.com/d5) describing the D5 analyzer, it says, “FDA Clearance in Process” and “For Export Only”. The phrase “FDA Clearance in Process” should be removed.

10. On the D5 analyzer webpage (https://www.drewscientific.com/d5), the D3 analyzer informational video is embedded. This should be removed.

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 address 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 any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Melissa Michurski, Director of Compliance Branch, at oradevices2firmresponse@fda.hhs.gov. Refer to CMS # (634208) when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer, Wendy Blame 334-273-4789 Ext 101 or at wendy.blame@fda.hhs.gov.

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 regulations 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 any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely yours,
/S/

Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health Operations
Division 2 Central

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