Is Nurse Assist, Inc Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

During an inspection of your firm, Nurse Assist, Inc., located in Haltom, Texas, on October 12, 2016, through November 23, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile IV saline flush syringes. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are medical 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.

2.    Failure to establish and maintain adequate procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). The CAPA procedures shall include requirements for (a) analyzing processes, work operations,quality audit reports, quality records, services records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; and (b) for investigating the causes of nonconformities relating to product, processes, and the quality system in order to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems. Specifically:

b.  Your firm did not investigate readings of bioburden samples from production lots manufactured between(b)(4)and(b)(4)that exceeded the action levels per WI042 Bioburden Testing Instructions, Revision 8, dated December 13, 2015. This resulted in the delay of corrective actions (i.e., performing additional sanitization of fill(b)(4), changing(b)(4), replacing(b)(4)and(b)(4), and implementing(b)(4)treatment of the water purification system) to reduce bioburden levels in your water purification system and fill lines until the first week of(b)(4).

Potential Health Risks

Consumers should be aware of potential risks associated with products from Nurse Assist, Inc.

Regulatory Context

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 regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1.    Failure to establish and maintain procedures to ensure that the device history records (DHR) for each batch, lot, or units are maintained to demonstrate that the devices are manufactured in accordance with the device master record, as required by 21 CFR 820.184.