Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bulcons-parvomay-ad-445156-12142014
Timestamp: 2020-07-03 20:49:24
Document Index: 360219439

Matched Legal Cases: ['art 113', 'arts 113', '§ 344', '§ 381', '§ 342', '§ 381', 'arts 108', 'art 110', '§ 379']

BULCONS PARVOMAY AD - 445156 - 12/14/2014 | FDA
BULCONS PARVOMAY AD - 445156 - 12/14/2014
BULCONS PARVOMAY AD MARCS-CMS 445156 — December 14, 2014
Ms. Svetlozara Mandova
1 Malina Street
4270 Parvomaj, Plovdiv
BULCONS PARVOMA Y AD
Parvomaj, Plovdiv 4270
Reference: #445156
Dear Ms. Mandova:
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) and acidified food processing facility, BULCONS PARVOMAY AD, located at 1 MALINA STREET, Parvomaj, Plovdiv 4270 Bulgaria, on September 8 - 9, 2014. During that inspection we found your firm had serious violations of the LACF and acidified food regulations, Title 21, Code of Federal Regulations, Part 113 and 114 (21 CFR Parts 113 and 114). At the conclusion of that inspection, our investigator issued an FDA Form 483, Inspectional Observations, which lists the observations of concern noted during the inspection. We acknowledge receipt of your response dated September 19, 2014. Our review of your response determined that your firm has not adequately addressed the deviations related to your LACF and acidified products, as further described in this letter.
As a manufacturer of LACF and acidified food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of the LACF and acidified food products you export to the United States. These regulations are described in 21 CFR 108, Emergency Permit Control, 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermitically Sealed Containers, and 21 CPR 114, Acidified Foods. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control (21 U.S.C. § 344). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35, 21 CFR113 and 114 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. § 381) when offered for entry into the United States.
Consequently, your violations of the mandatory requirements set forth in 21 CFR 113 and 114 render your LACF and acidified food products adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)). You can find the Act, the LACF, and the acidified foods regulations through links in FDA's home page at www.fda.gov.
1. Your firm failed to have your firm's six (6) still water retorts equipped with a temperature recording device as required by 113.40(b)(2). Specifically, you do not have a temperature recording device to permanently record the temperature of the retort during processing of your LACF products. Also your firm's acidified food processing records do not comply with the requirements of 114.100(b) in that, although they do contain a temperature entry for each batch, they do not provide sufficient thermal processing information to permit a public health evaluation of the process.
Your firm's response indicates that procedures were started for implementation of a new system for monitoring and recording the critical factors as well as automation of the autoclaving process, which is to be finished by the end of October. Your response is inadequate in that it does not indicate what you have done in the interim with respect to any LACF or acidified food products processed in these retorts before the temperature recording systems were installed and in operation.
2. Your firm failed to have your firm's six (6) still water retorts equipped with water level indicators as required by 113.40(b)(9). Specifically, your retorts do not have water level indicators that show the level of water within the retort/autoclave. Also your firm could not assure that every container of acidified food was immersed in water and therefore received a sufficient thermal process as required by 114.80(a)(1).
Your firm's response indicates that procedures were started for implementation of a new system for monitoring and recording the critical factors as well as automation of the autoclaving process, to be finished by the end of October. Your response is inadequate in that it does not indicate what you have done in the interim with respect to any LACF or acidified food products processed in these retorts before the water level indicators were installed and functioning.
3. Your firm's container code on your LACF products failed to identify the establishment where packed, product, year, day and period when packed as required by 21 CFR 113.60(c). Specifically, the container codes on your LACF products only contain the expiration date and a batch number and no other identification information.
Your firm's response indicates you plan to readjust your printers to include all of the required information for container identification by the end of October. Your response is inadequate in that it does not indicate what you have done in the interim with respect to any products processed and coded before the change to include all required information in your firm's container codes; nor did you include an example of your new container codes.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response, documentation, such as, at least five (5) days of production records, to demonstrate that you have implemented the revisions indicated in your response and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF and acidified food products under section 801(a) of the Act, 21 U.S.C. § 381(a), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the LACF and acidified food regulations (21 CFR 108, 113 and 114) is Import Alert #99-38. This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms_ia/importalert_1132.html.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the LACF and acidified food regulations (21 CFR Parts 108, 113 and 114), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Donald W. Greaves, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Mr. Greaves at (240) 402-2057 or via email at donald.greaves@fda.hhs.gov
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