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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Polychrome Medical, Inc 07-Dec-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612)758-7133
FAX: (612)334-4142

December 7, 2007


Refer to MIN 08-05

Cydney A. Einck
President and Owner
Polychrome Medical, Inc.
2700 Freeway Boulevard, Suite 750
Brooklyn Center, Minnesota 55430-1748

Dear Ms. Einck:

During an inspection of your firm located in Brooklyn Center, MN, on August 14-20, 2007, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures CF (Cystic Fibrosis) Indicator Sweat Test Systems. 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, (21 CFR) Part 820. These violations include, but are not limited to, the following:

1. Failure to maintain device master records that are prepared and approved in accordance with the QS regulations, as required by 21 CFR 820.181. A review of batch records from the last two years of production for the Cystic Fibrosis Indicator Sweat Test System showed that you have not followed a Device Master Batch record. It was unclear how much of each raw material was added, what specifications were followed, and identity of the individual conducting the manufacturing.

2. Failure to develop, conduct, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). You lacked documentation of quality assurance acceptance or review throughout the manufacturing process from receiving, production, testing, final packaging, to final release of this device. There were 34 CF Indicator Sweat Test units placed into quarantine due to failures or returned product. You failed to document the analysis of quality data and investigation of the cause of the nonconformities.

3. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups, as required by 21 CFR 820.60. You did not document the correct lot numbers of the raw materials used to manufacture the Pilocarpine Interface pads, Chloride concentration test patches, and Potassium Sulfate Interface Pads, all of which were part of the CF Indicator Sweat Test System in the following Lot Travelers: P000620, P000650, P000660, P000670, P000680, P000690, P000700, P000730, P000780, P000790, P000800, P000820, P000830, P000840, P000850, P000860, P000880, and P000890.

4. Failure to inspect, test, or otherwise verify incoming product for conformance to specifications, as required by 21 CFR 820.80(b). You have not tested nor established test specifications for the active ingredient Pilocarpine Nitrate 1% that is used as an ingredient in the manufacturing of the test kits that are part of the Sweat Test Indicator System.

5. Failure to establish, define, document and implement procedures for acceptance or rejection of finished device production runs, lots, or batches as required by 21 CFR 820.80(d). You have not developed and implemented procedures for acceptance or rejection of finished Sweat Test Kits prior to distribution. For example, there was no documentation of quality assurance testing in the batch lots reviewed between 1/1/07 and 8/14/07.

6. Failure to establish and maintain procedures for implementing corrective and preventive actions as required by 21 CFR 820.100(a). You do not have written, corrective and preventive action procedures.

7. Failure to document corrective and preventive action activities, including analysis of sources of quality data, investigations of causes of nonconformities, the actions needed to correct or prevent recurrence of nonconforming product and other quality problems, the verification or validation of corrective actions, and implementation of corrective and preventive actions as required by 21 CFR 820.100(b). As of January 2007, your firm changed the design of your [redacted] of the CF Indicator Sweat Test System due to customer complaints of device failures. You failed to document the verification or validation of the design change of the [redacted]

8. Failure of management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20. For example, many of the deficiencies noted during this inspection were also noted du ring FDA's previous inspection of you firm. A four-item List of Inspectional Observations, FDA 483, was issued to you at the conclusion of FDA's inspection of your firm in 2003. Many of the observations list in the 2003 FDA 483 were also observed in during FDA's most recent inspection. The repeat observations, as well as additional Quality System deficiencies, were reported on the FDA 483 issued during the current inspection.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure compliance with the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action to bring your products into compliance.

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, no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.

You should take prompt action to correct the deviations described in this letter. Failure to promptly correct these deviations 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.

Please notify this office in writing within 15 working days to acknowledge receipt of this letter and to provide an update on the status of your corrective actions. Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead.


W. Charles Becoat
Minneapolis District