| Public Health Service Food and Drug Administration |
Detroit District FAX: 313-393-81390 |
Department of Health and Human ServicesWARNING LETTER
(2010-DT-10)
March 26, 2010
Mr. Peter W. Paisley, CEO
Liquid Manufacturing, LLC
6150 Whitmore Lake Road
Brighton, Michigan 48116-1926
Dear Mr. Paisley,
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 6150 Whitmore Lake Road, Brighton, Michigan on the following dates: January 9-14,19, and 21, 2010. FDA initiated the inspection in response to a consumer complaint involving swollen pouches of (b)(4) baby food products that your facility manufactured. The inspection determined that your facility produced acidified foods and other acid food products and revealed that you have significant deviations from the requirements of 21 CFR Part 108, 21 CFR Part 114, and 21 CFR Part 110
These significant deviations caused your acidified food products and acid food products to be adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C.§ 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, and within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342 (a)(4)] in that they have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. The Act and regulations can be found on FDA's webpage at www.FDA.gov.
As an acidified food processor, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and regulations relating to the processing of acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor fails to fulfill the mandatory requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements within 21 CFR Part 114.
FDA's inspection revealed a series of container closure failures resulting in unsealed product pouches contaminating the overall production system, including water used for cooling. Further, insufficient container closures created a route for contamination of the finished products. The container closure system in use during our inspection for your pouch products exhibited serious deficiencies in assembling containers consistently and correctly. Therefore, the finished product pouches and system your firm utilized to seal such containers was not adequately protecting the food against contamination.
Based on FDA's findings, the Michigan Department of Agriculture (MDA) issued your firm a license limitation/Special Report on January 14,2010, which restricts your firm from processing and distributing acidified "baby food". We also acknowledge that on January 10, 2010 during FDA's inspection, you voluntarily agreed to stop shipping any (b)(4) and (b)(4) products and voluntarily recalled (b)(4) stage (b)(4) and (b)(4) stage (b)(4) and (b)(4) products. Before you resume operations for these baby food products, we expect you to identify and correct the point of malfunction in your fitment/capping equipment to ensure that this problem is completely resolved and does not happen again.
During our investigation of your swollen and improperly sealed products. FDA conducted field examinations of a variety of (b)(4) and (b)(4)finished product pouches in storage at your facility and at a customer warehouse and numerous abnormal (swollen) containers and observed leaking containers. FDA collected and tested fourteen samples consisting of normal and abnormal finished product containers and our laboratory confirmed that your products contained molds and yeasts, and that packaging showed microleaks in damaged pouch seams.
During the inspection, we found that you have serious deviations from the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114). The investigators discussed with you observations noted on the Form FDA-483, lnspectional Observations, which was issued to you on January 21, 2010. We noted the following serious acidified food violations:
• As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, your firm has failed to file a scheduled process for all acidified foods products you manufacture.
FDA acknowledges that your firm currently has two processes on file for the following products: (b)(4) and (b)(4). These processes were submitted to FDA on February 3 and 10, 2010, after the close of this inspection. Prior to packing any new acidified or low-acid food products, your firm must file scheduled processes with FDA. Your firm also registered with FDA on January 20, 2010 in accordance with 21 CFR 108.25 (c)(1).
• You must test and examine containers often enough to ensure that containers suitably protect the food from leakage and contamination as required by 21 CFR 114.80(a)(4). However, investigators examined cartons of finished product and found swollen pouches (b)(4) Lot (b)(4) and (b)(4) Lot (b)(4). In addition swollen pouches and one leaking pouch were observed in cartons of (b)(4) Lot (b)(4) and (b)(4) and one leaking pouch of (b)(4) Lot (b)(4) was observed. The condition of these pouches indicates that your firm is not conducting container integrity testing at sufficient frequency to ensure the containers are protected from leakage and contamination.
FDA acknowledges that your firm's February 11, 2010 response identifies corrective actions such as increasing the frequency of vacuum chamber testing during production and purchasing new package integrity equipment. We do not consider your February response acceptable. As stated above, identifying and correcting the point of malfunction in the fitment/capping equipment remains a significant concern and must be completely resolved to ensure that this problem does not happen again.
The above is not intended to be an all-inclusive list of violations. As a processor of human foods you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. You should take prompt action to correct the violations described in this letter and establish and implement procedures which will prevent them from occurring in the future. Receipt of this Warning Letter from the FDA does not, in any way, diminish the effect of the MDA license limitation. Failure to take appropriate correction action may subject your firm and products to further actions, such as emergency permit control, injunction or seizure.
You should notify this office, in writing, describing the corrective actions that you will take to bring your firm into compliance within fifteen (15) working days of receiving this letter. Your response should include each corrective action that you have or will take to correct these violations and, in particular, what methods and controls you will implement to prevent their recurrence. Please include copies of any documentation that demonstrates that the corrections have been implemented.
Your written response should be sent to Tina M. Pawlowski, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed. If you have any questions concerning this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by e-mail at tina.pawlowski@fda.hs.gov.
Sincerely,
/s/
Joann M, Givens
District Director
Detroit District Office
Cc: Michigan Department of Agriculture
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