What is needed for FDA QSR compliance as a Specification Developer

Recently, there was a warning letter issued to a company (dated Sept 11, 2012) that was registered as a “specification developer” with the FDA. The inspection of the company was conducted by the FDA on June 7, 2012.

However, this article is not about the company and what they manufactured or what they distributed. This article is about what the FDA is expecting from a Specification Developer for complying with the QSR/cGMP which we can very clearly determine from reviewing this warning letter.

Take notice that if your company has no manufacturing activities on site and all you do is provide written specifications to a contract manufacturer who produces these medical devices for you, do not naively assume that QSR compliance is not your company’s concern and applies to the contract manufacturer only. The FDA regulations state that specification developers are subject to the GMP requirements for the activities they conduct. These could include but may not be limited to various design controls including correct transfer of the design information to a contract manufacturer, implementing adequate device master record, change control and maintaining a complaint file and processing complaints if the specification developer also distributed their devices.

We find the following points in the FDA warning letter as they relate to the FDA expectations for a specifications developer QSR compliance(these were taken directly from the FDA warning letter):

1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm does not have established corrective and preventive action procedures.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm does not have established purchasing control procedures.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm does not maintain a complaint file, nor are there any complaint handling procedures.
4. Failure to ensure that management with executive responsibility establishes its policy and objectives for, and commitment to, quality; and failure to ensure that management with executive responsibility ensures that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 CFR 820.20(a). For example, your firm has no established quality policy or quality objectives.
5. Failure to establish procedures for quality audits and 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, your firm does not have an established quality audit procedure, nor have there been any quality audits performed.
6. Failure to maintain device master records (DMR) and ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, device master records for the devices are not maintained.
7. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184. For example, device history records for the devices are not maintained.
8. Failure to maintain a quality system record that includes, or refers to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device, including, but not limited to, the records required by 21 CFR 820.20, as required by 21 CFR 820.186. For example, a quality system record is not maintained.

As you can see, in this warning letter the FDA is expecting quite a bit of documentation and “documentation control” for a company that declares themselves as a specification developer.

The Warning Letter goes further to state:
We reviewed your firm’s response and conclude that it is not adequate. The response did not provide any specific plan or evidence of any corrections, corrective actions, and systemic corrective actions to address these observations. Your firm states that you manufacture nothing, but only distribute other manufacturers’ registered and cleared products. However, the inspection revealed that for your products you are the specification developer and therefore subject to the current good manufacturing practice requirements.

In this case the company held the 510(k) for the devices and had them contract manufactured by another company.

This warning letter example shows the FDA is taking a hard look at the specification developers in the same way they do with the manufacturers in requiring them to maintain compliant quality system to assure the devices they put into the marketplace meet specifications. We have also observed that if the specification developer does not control the contract manufacturer by conducting periodic audits and reviewing their quality documents, this could lead to additional regulatory actions. The FDA considers your contract manufacturer as a branch of your company. If a contractor is audited by the FDA and found to be in violation of QSR, the Agency could send a warning letter not just to your contract manufacturer but to you as well for not controlling the contractor.

?If you would like to discuss anything in the article or you are a specification developer and need more information on what is required by you to assure FDA compliance, please contact mdi at [email protected] and reference: Specification Developer.