Inspections, Compliance, Enforcement, and Criminal Investigations
AJP Scientific, Inc. 02-Mar-06
Department of Health and Human Services
Public Health Service
New Jersey District Office
March 2, 2006
RETURN RECEIPT REQUESTED
Mr. Henry Eng
AJP Scientific, Inc. (Eng Scientific, Inc.)
82 Industrial East
Clifton, NJ 07012
Dear Mr. Eng:
During an inspection of your firm (AJP Scientific, Inc.) located at 82 Industrial East, Clifton, New Jersey from January 19 through January 26, 2006, an investigator from this office determined that you are a manufacturer of Fetal Hemoglobin Differential Staining Kits and Semen Analysis Kits, which are regulated as Class lI medical devices within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
The above-stated inspection revealed that your devices described above 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, packaging, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), part 820. Significant deviations include, but are not limited to, the following:
1. Your firm failed to establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR § 820.100(a). Specifically, your firm has not established procedures to analyze and document quality data to identify and investigate existing or potential causes of nonconforming products or other quality problems, as well as procedures to verify, validate and implement corrective and preventive actions and ensure that relevant information is submitted for management review. Furthermore, your firm failed to document any CAPA activities and their results.
2. Your firm failed to maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR § 820.198(a). Specifically, in response to a FDA483 observation in 1997, your firm submitted a written procedure for handling complaint files. However, this procedure was not maintained as a part of your current Quality System. Furthermore, the new complaint procedure presented at the close of the inspection after the issue was raised by our Investigator fails to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR part 803 (Medical Device Reporting).
3. Management with executive responsibility has not ensured 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:
A) Your firm's management with executive responsibility has failed to ensure that your organization's personnel understands and implements a quality policy. Furthermore, your management's representative appointed during the inspection after the issue was raised by our Investigator must be examined for potential conflicts of interest in order to ensure that the effectiveness of the quality system is not compromised.
B) Your firm failed to establish procedures for management review at appropriate intervals in order to ensure the effectiveness of your quality system is being adequately met.
C) Your firm failed to establish a quality plan which defines the quality practices, resources, and activities relevant to your Fetal Hemoglobin Differential Staining Kits and Semen Analysis Kits.
D) Your firm failed to establish quality system procedures which show how each element of the quality system requirements is met.
4. You lack written procedures for addressing the identification, documentation, evaluation, segregation, disposition, and investigation of nonconforming product as required by 21 CFR§ 820.90(a). Specifically, your firm lacks procedures for the handling and disposition of nonconforming product for your Fetal Hemoglobin Differential Staining Kits and Semen Analysis Kits.
5. Your device master record for your Fetal Hemoglobin Stain device failed to include or refer to the location of all device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods as required by 21 CFR § 820.181.
6. You lack written procedures and documented purchasing controls, as required by 21 CFR§ 820.50, specifically supplier requirements, evaluation activities, and other controls exercised over incoming materials and products.
7. You lack written procedures to control and document incoming acceptance activities, as required by 21 CFR § 820.80(b). Specifically, your firm failed to maintain procedures until after the issue was raised by our Investigator for incoming acceptance activities which would include inspections, tests, or otherwise verified as conforming to specified requirements.
The January 2006 inspection also revealed that your Fetal Hemoglobin Differential Staining Kits and Semen Analysis Kits are misbranded within the meaning of section 502(t)(2) of the Act (21 U.S.C.§ 352(t)(2)), in that your firm failed to furnish material or information respecting the devices that is required by or under section 519 of the Act (21 U.S.C. § 360i), as specified in the Medical Device Reporting (MDR) regulation, 21 CFR part 803. More specifically, in response to a FDA483 observation in 1997, your firm submitted a written procedure for handling MDR events. However, your firm failed to implement and maintain this procedure for the handling events that may be reportable as medical device reports, as required by 21 CFR § 803.17.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and FDA's regulations. The specific violations noted in this letter and on the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems within your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective and preventive actions.
We note your acknowledgement during the inspection to correcting the deficiencies related to your quality system and your promise to implement corrections. However, this inspection determined that you have not corrected the major deficiencies from the previous inspection, which took place on March 17 and 18, 2003.
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. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice to you. These actions include, but are not limited to, seizure, injunction and/or civil money penalties.
Please notify this office in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be directed to the New Jersey District, FDA, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Robert J. Maffei, Compliance Officer.
Douglas I. Ellsworth
New Jersey District