As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Lianyungang Aikang Food Co., Ltd — Lianyungang, Jiangsu, China
The Food and Drug Administration sent a warning letter dated Dec. 04, 2019, to Mr. Chuanai Li, President of Lianyungang Aikang Food Co., Ltd.
During an inspection at Lianyungang Aikang Food Co., Ltd, acidified food facility on July 8-9, FDA investigators found serious violations of the Emergency Permit Control regulation [Title 21 of the Code of Federal Regulations (CFR), Part 108 (21 CFR Part 108)] and the Acidified Foods (AF) regulation (21 CFR Part 114).
In response to these deviations, the FDA issued an FDA-483 Inspectional Observations form that lists deviations observed at the facility.
The violations noted by the FDA:
- “Your firm failed to implement appropriate quality control procedures, including frequent testing and recording of results, to ensure that finished foods do not present a health hazard as required by 21 CFR 114.80(a).”
- “On July 9, 2019 at 14:29, our investigator observed a pH test result record in the laboratory desk area for canned peaches dated July 9, 2019 that contained entries that could not have been the result of actual testing because the entries reflected contemporaneous and future times (“(redacted)“, “(redacted)“, and “(redacted)“). Your laboratory employee then presented a second record for the same product dated June 9, 2019 completed with times prior to 14:29.”
“During the close out of the inspection, our FDA investigator explained that records have to be documented at the time that the activity is observed or conducted to reflect actual testing results. These pre-filled records demonstrate a lack of appropriate quality control procedures.”
- “On July 9, 2019 at 14:29, our investigator observed sweet packing fluid mixing records in the laboratory desk area filled with data and dates ((redacted)) but with no associated product information entered on the records. When the individual dates of the mixing records were compared to manufacturing records in the record room, it was observed that there were either no manufacturing records for such dates or there was a duplicate of the record for that date containing conflicting data. Specifically, the FDA investigator noted a record of the packing fluid mixing record dated “(redacted)” stapled in the complete batch record located in the firm’s record room and compared it with packing fluid mixing records dated “(redacted)” found in the laboratory and determined that the (redacted) records for the packing fluid mixing for the same date contained different testing results. These mixing records with no matching or conflicting manufacturing records demonstrate a lack of appropriate quality control procedures.”
“In a post-inspectional ” Letter of apology to FDA inspection panel” dated July 11, 2019, your firm has implemented “(redacted)” within your processing facility. Your July 30, 2019, response indicated products were re-tested, that you updated management and training Standard Operating Procedures (SOPs) and responsibilities, that you updated Corporate Integrity Management System and Employee Reward and Punishment System procedures, and provided training records, specifically for the canned peach products. We are unable to evaluate the adequacy of your response because you did not provide supporting documentation specific to the issue of pre-filled records and records with no matching manufacturing records.”
- “You did not test and examine containers often enough to ensure that the containers suitably protected the food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, your firm is not conducting frequent can examinations to identify dented cans during the different processing steps. On July 8, 2019 and July 9, 2019, we observed multiple cans with significant deformation in close proximity to the can seams. Damaged cans were observed throughout the facility at the following production (redacted): prior to syrup addition, after exiting the lid sealer machine, after the (redacted) step, and in finished product storage.”
“Your July 30, 2019, response indicated you contracted with Shandong Keno Machinery Technology to conduct a field analysis on can deformation and inspection for incoming cans. However, we are unable to evaluate the adequacy of your response because you did not provide supporting documentation. Your response did not include the type of testing being conducted on finished product cans for FDA review. Also, the response did not address the disposition of the deformed cans observed during the inspection and inspected by Shandong Keno Machinery Technology.”
- “You did not maintain processing and production records showing adherence to the scheduled process as required by 21 CFR 114.100(b).”
- “No production records were available for the manufacture of (redacted) cans, size (redacted) grams, of peach products manufactured on July 5, 2019, and identified as: (redacted) and (redacted) cans of the same product manufactured on July 6, 2019, with the following manufacturing information: (redacted).”
- “On July 8, 2019 we conducted a review of your firm’s processing records and identified the following failures to maintain processing and production records:”
- “No pH meter calibrations records were available. Processing and production records must include records of pH measurements and other critical factors intended to ensure a safe product.”
- “Production records were missing product information including lot number, product name, production date, and/or container size. Processing and production records must include sufficient information such as product code, date, container size, and product, to permit a public health hazard evaluation of the processes applied to each lot, batch, or other portion of production.”
iii. “We observed an employee entering the time of (redacted) when the actual time was (redacted) into a production record at the lid sealing machine area. Records must be documented at the time that the activity is observed or conducted to ensure that the record accurately reflects adherence to the scheduled process.”
- “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR Part 114 and 21 CFR Part 117, Current Good Manufacturing Practices, Hazard Analysis and Risk-Based Preventive Controls for Human Foods Subparts to assist your firm in meeting Current Good Manufacturing Practices (CGMP) requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.”
- “During the inspection, we observed a (redacted) jar labeled with a preparation date of July 7, 2019, and an expiration date of August 6, 2019. Your firm prepares pH buffer solution from a powder but does not have written instructions for pH buffer solution preparation, storage, or pH meter calibration. We note that pH buffer solution prepared from a powder buffer mix appears to expire a few days after preparation according to the pH buffer manufacturer’s website.”
A complete list of the violations can be found in the FDA’s warning letter.
El Molino Bakery Supplies Inc — Duluth, GA
The Food and Drug Administration sent a warning letter dated Dec. 16, 2019, to Diana Ortegon, General Manager of El Molino Bakery Supplies Inc.
FDA investigators conducted a Foreign Supplier Verification Program (FSVP) inspection at El Molino Bakery Supplies Inc on July 10, 2018, and Sept. 12, 2019. The inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The warning letter says that, “During our September 12, 2019 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the products that you import from your foreign supplier. Your firm did not have FSVPs for the products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.”
In response to these deviations, the FDA issued an FDA 483a Inspectional Observations form that lists deviations observed at the facility.
The violations noted by the FDA:
“Your firm did not have FSVPs for the products that you import. This was the case during the September 12, 2019 inspection, as well as the July 10, 2018 inspection. Some of the products for which you did not have an FSVP include Multi-color sprinkles, Strawberry filling, and Bavarian cream manufactured by (redacted).”
“The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.”
“You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of Multi-color sprinkles, Strawberry filling, and Bavarian cream manufactured by (redacted). We may place these foods on detention without physical examination (DWPE) when you import the products.”
A complete list of the violations can be found on the FDA’s warning letter page.
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