Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Consolidated Industries LLC 03-Dec-07
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REOUESTED
December 3, 2007
Robert L. Ruck
Pacific Consolidated Industries LLC
12201 Magnolia Ave.
Riverside, CA 92503
Dear Mr. Ruck:
During an inspection of your establishment located in Riverside, California on April 17 through 27, 2007, investigators from the Food and Drug Administration (FDA) determined that your firm manufactures portable air separation devices. 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 function of the body.
The above-stated 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) regulations found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. At the close of the inspection, you were issued a Form FDA-483, List of Inspectional Observations, that identified a number of violations, including, but not limited to, the following:
1. Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 C.F.R. § 820.30(i). For example, your document change control procedure does not ensure that design changes are verified and lacks criteria to determine whether a design change required verification or validation before its implementation.
2. Failure to establish and maintain procedures for validating the device design by performing the validation under defined operating conditions on initial production units, lots, or batches, or their equivalents, as required by 21 C.F.R. § 820.30(g). For example, the design of the Expeditionary Deployable Oxygen Concentration System (EDOCS120B) Design was not validated using production units under actual or simulated use conditions.
3. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device and to include a mechanism for addressing incomplete, ambiguous, or conflicting requirements, as required by 21 C.F.R. § 820.30(c). For example, your design history file for the EDOCS-120B contains multiple instances of conflicting requirements.
4. Failure to establish and maintain procedure for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. § 820.198(a). For example, Section [redacted] of the complaint handling procedure, [redacted], was not followed to ensure that the complaint report includes device serial numbers or documented attempts to obtain the serial numbers.
5. Failure to maintain device history records that include, or refer to the location of, acceptance records which demonstrate that the device is manufactured in accordance with the Device Master Record and QS requirements, as required by 21 C.F.R. §§ 820.80(e) and 820.84(d). For example, the EDOCS-120B acceptance records in the device history file did not include a documented justification for changes in test specifications.
6. Failure to document personnel training, as required by 21 C.F.R. § 820.25(b).
We have received your firm's written responses, [redacted] to the FDA-483, Inspectional Observations, issued at the conclusion of the inspection. We have reviewed your responses along with the additional data requested and provided. Your responses indicate a lack of control within your firm and a lack of understanding of and/or commitment to the QS regulations. Also, you have not clearly identified each document provided with the responses and have not adequately explained how the documents that you submitted apply to the observations cited in the FDA-483. Moreover, rather than provide documentation of permanent, comprehensive corrections, your responses suggest additional violations of the QS regulations. For example, the product support bulletins for the sieve bed maintenance frequency do not identify the changes for each revision to the recipient and actually have conflicting statements regarding maintenance frequency:
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Also, 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, premarket approval applications for Class III device to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Pamela B. Sehweikect, Director
Compliance Branch, Los Angeles District
U.S. Food & Drug Administration
Irvine, CA 92612
If you have any questions, please contact Barbara Rincon, Compliance Officer, at (949) 608-4439.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Alonza E. Cruse
Cc: Department of Health Services
Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413