- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMohammed Musalam
- Pasha Food Distribution USA, Inc.
18375 Ventura Blvd, #247
Tarzana, CA 91356-4218
- Issuing Office:
- Division of West Coast Imports
May 18, 2020
Re: CMS # 607108
Dear Mr. Musalam:
On March 18, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Pasha Food Distribution USA, Inc., located at 9813 Independence Avenue, Chatsworth, California 91311-4320. We also conducted an inspection on September 12, 2018. These inspections were 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 FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the roasted eggplant product you import from (b)(4), and dried sumac and tahini products manufactured by (b)(4). You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection and the follow-up inspection on March 18, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your email response dated March 30, 2020. In your email, you declared you are a very small importer with sales less than $(b)(4) per year. However, we could not evaluate this response because you did not provide supporting documentation that you meet the definition of a very small importer (see 21 CFR 1.500 for the definition of very small importer). Furthermore, even if you meet the definition of very small importer, you are still required to follow FSVP requirements. If you choose to comply with the requirements for very small importers, you must document that you meet the definition of very small importer in 21 CFR 1.500 before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year (21 CFR 1.512(b)(1)(i)(A)). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)). We could not evaluate whether you are in compliance with these supplier verification requirements for very small importers because, while your response includes letters from your (b)(4) suppliers, these letters do not address the suppliers’ compliance with the relevant food safety standards and you did not explain how the letters apply to your compliance with the requirements of the FSVP regulation. The letter from (b)(4) states that the establishment “has FDA Registration” and has been producing certain products. The letter from (b)(4) states that the establishment is a “registered production facility” with FDA and “our company is producing food products like Tahini ad Sumac in compliance with USA FDA Regulations.”
Your significant violations of the FSVP regulation are as follows:
- You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for roasted eggplant manufactured by (b)(4), and dried sumac and tahini manufactured by (b)(4).
If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).
Failure to Register Food Facility:
In addition, FDA has determined that your facility at 9813 Independence Avenue, Chatsworth, California 91311-4320 is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection, you were advised of this requirement. Our records indicate that you did not register your facility as required. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [U.S.C. § 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
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 roasted eggplant imported from (b)(4) and dried sumac and tahini imported from (b)(4). We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act [21 U.S.C. 331(zz)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation.) If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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.
Please send your reply to Food and Drug Administration, Attention: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact James Ahlrep via email at firstname.lastname@example.org. Please reference CMS # 607108 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Dan R. Solis
Program Division Director
Division of West Coast Imports