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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Majestic International Spice 16-Nov-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900



WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

November 16, 2005

W/L 07-06

Salim Mavany, President/Owner
Anwar Mavany, Operations Manager
Majestic International Spice
1725 Gage Road
Montebello, CA 90640

Dear Messrs. Salim and Anwar Mavany:

On March 1, 2005, your firm, Majestic International Spice ("Majestic") offered for import into the United States a shipment containing [redacted] bags of "Extra Fancy Basil" from Al Dahlia Company in Egypt under entry [redacted]. On March 10, 2005, the extra fancy basil was Detained Without Physical Examination pursuant to Import Alert 99-19, entitled "DETENTION WITHOUT PHYSICAL EXAMINATION OF FOOD PRODUCTS DUE TO THE PRESENCE OF SALMONELLA." According to Import Alert 99-19, a prior shipment of basil from A1 Dahlia had been sampled and found to contain Salmonella. The following day, March 11, 2005, FDA sent you written notice of the detention, which Anwar Mavany subsequently acknowledged receiving.

On May 31, 2005, the U.S. Food and Drug Administration (FDA) received a private laboratory report contair:::ig test results for basil that Majestic had submitted for testing in response to the FDA detention notice. The private laboratory's report indicated that the basil it tested was negative for Salmonella.

On June 14, 2005, an FDA investigator went to Majestic to examine the basil shipment and to collect a sample for testing by an FDA laboratory. The investigator found that [redacted] of the [redacted] bags from the entry were not at Majestic. Anwar Mavany stated in a June 14, 2005 affidavit that these bags already had been distributed to customers. According to Anwar Mavany, [redacted] of the bags had been sold to [redacted] bags had been sold to [redacted] and [redacted] bags were a "net volume loss" resulting-Trom the process of grinding up the basil leaves. The investigator collected an audit sample from the remaining bags and submitted the sample to an FDA laboratory for testing. The FDA laboratory subsequently found the basil to contain Salmonella Poly B.

Section 301(a) of the Federal Food, Drug and Cosmetic Act (the "Act") (21 U.S.C. §331(a)) prohibits the introduction or delivery for introduction or causing the introduction or delivery for introduction into interstate commerce of any food that is adulterated. Section 301(c) of the Act (21 U.S.C. § 331(c)) prohibits the receipt in interstate commerce of any food that is adulterated, and the delivery or proffered delivery thereof for pay or otherwise. Section 402(a)(1) of the Act (21 U.S.C. § 342(a)(1)) provides that a food is adulterated if bears or contains any poisonous and deleterious substance which may render it injurious to health. The basil imported under [redacted] from [redacted] was adulterated under Section 402(a)(1), because it contained Salmonella Poly B, a poisonous and deleterious substance that may render the basil injurious to health. Accordingly, the distribution of the basil imported under [redacted] violated sections 301(a) and (c) of the Act (21 U.S.C. §§ 331(a) and (c)).

Violations of Section 301 of the Act can result in civil and/or criminal penalties. For example, Section 303(a)(1) of the Act (21 U.S.C. § 333(a)(1)) provides for imprisonment for not more than one year and/or a fine of not more than $1,000 for any person who violates a provision of Section 301 (21 U.S.C. § 331). Section 303(a)(2) (21 U.S.C. § 333(a)(2)) provides, in part, for imprisonment for not more than three years and/or a fine of not more than $10,000 for any person who violates a provision of Section 301 "with the intent to defraud or mislead."

On June 14, 2005, Anwar Mavany submitted an affidavit to an FDA investigator, in which he stated that Majestic distributed [redacted] of the bags [redacted] of basil imported under [redacted] to two customers - [redacted] and [redacted] Anwar Mavany also stated in the affidavit that he had already talked to these two customers and asked them to hold the basil until the FDA audit sample had been tested
and FDA had cleared the basil for distribution. Anwar Mavany, however, did not provide the FDA Investigator with any invoices or shipping records to document the distribution of the basil to these customers. Anwar Mavany stated in his affidavit that he would send copies of the sales receipts to the FDA investigator by facsimile by June 15, 2005.

On July 1, 2005, an FDA investigator called Anwar Mavany and informed him of the FDA Laboratory's finding of Salmonella Poly B in its test of the basil sample audited on June 14, 2005. In response, Anwar Mavany stated to the FDA investigator that Majestic would initiate a voluntary recall . The investigator also requested Mr. Mavany provide a written letter by facsimile confirming Majestic's intentions to initiate a recall, a strategy for conducting the recall, as well as a copy of the distribution list for the basil imported under [redacted], Contrary to Anwar Mavany's assurances in his June 14, 2005 affidavit, the distribution list still had not been provided to FDA.

Later in the day on July 1, 2005, the FDA investigator received a letter by facsimile from Anwar Mavany. The letter merely stated that Majestic "[a]gree[s] to a voluntary recall of basil imported under, [redacted]" The letter did not include a recall strategy or a copy of ,the previously promised distribution list for the basil imported under [redacted].

On July 5, 2005, still not having received the recall strategy or the distribution list, the FDA investigator called Majestic and spoke with Salim Mavany, Anwar Mavany's son, who stated that his father had not discussed the recall with him. Salim Mavany further stated that Anwar Mavany was sick and would not be in the office that day, but he (Salim Mavany) would attempt to get the information to the investigator by the end of the day.

On July 6, 2005, Anwar Mavany sent a letter by facsimile to the FDA investigator containing a list of companies to whom the basil imported under [redacted] purportedly had been distributed. The letter identified five companies to whom the basil imported under, [redacted] allegedly had been distributed. In his June 14, 2005 affidavit, Anwar Mavany explicitly stated that the basil only had been distributed to two
customers - [redacted] and [redacted]. The letter, moreover, did not provide contact information or addresses for any of the companies listed in the letter. However, Anwar Mavany stated in the letter that Majestic was "[n]ow calling our customerss as instructed.

On July 7, 2005, two FDA Investigators went to Majestic and met with Anwar Mavany. The investigators obtained the addresses and contact information for the five companies identified on the distribution list. Anwar Mavany told the investigators that Majestic only had called two of the five companies on the list to notify them of the recall. According to Anwar Mavany, one of the two companies, [redacted] told him that they have most if not all of the [redacted] tbags of basil that they had purchased from Majestic. Anwar Mavany also provided a written recall strategy to the investigators, in which he stated that Majestic would call each of the customers to whom the basil had been distributed to notify them of the recall and follow-up the call with a letter. The recall strategy letter also stated that Majestic would "advise" FDA once they have "any information."

During the July 7, 2005 meeting at Majestic, the FDA investigators requested to verify that the remaining [redacted] bags of basil that FDA had observed on June 14, 2005 were still being held by Majestic. Anwar Mavany stated that, contrary to the information provided to the FDA investigator on June 14, 2005, only [redacted] of the [redacted] bags contained basil; the other [redacted] bags actually contained marjoram. One of the investigators opened one of the bags labeled "Extra Fancy Basil" and confirmed that it indeed contained marjorum.
Anwar Mavany also disclosed for the first time that Majestic had located another [redacted] bags of basil that it had not accounted for during the FDA investigator's visit to the firm on June 14, 2005, and that these [redacted] bags had been ground and put into drums. Anwar Mavany showed the investigator [redacted] drums labeled as containing [redacted] of "Ground Basil" and one drum filled to about 25% capacity . Majestic, therefore, had identified [redacted] bags of basil that it received under entry [redacted]. The invoice for entry [redacted] however, states that only [redacted] bags were received. Anwar Mavany also submitted an affidavit to the investigators on July 7, 2005, in which he stated that the"discrepancy in the quantity of bags . . . is due to lack of or incorrect labeling of bags received and stored in our warehouse."

On or about August 9, 2005, an FDA investigator called Majestic to follow-up on Majestic's recall of the basil. The investigator spoke with Anwar Mavany, who stated that all of the recalled basil had been returned to Majestic. On August 11, 2005, the investigator went to Majestic and took pictures of the basil that Anwar Mavany claimed had been returned pursuant to the recall. The investigator observed that most of the basil was not in its original state; only [redacted] of the original [redacted] bags looked like the original shipment. Anwar Mavany stated that the remaining bags had been returned in small bags and cartons, and that they had repacked them into plastic bags and drums. Anwar Mavany was unable to provide the investigator with records documenting the return of the basil, but stated that he would get the information to the investigator. Anwar Mavany also presented to the investigator copies of three recall letters that he claimed to have sent to the customers who purchased the basil imported under entry [redacted]despite the fact that the distribution list Anwar Mavany previously submttted to FDA identified five customers who received the basil.

On August 17, 2005, the FDA investigator returned to Majestic and met with Anwar Mavany, who submitted another affidavit to the investigator. In the affidavit, Anwar Mavany stated that Majestic had received all of the recalled basil, except for [redacted] bags that had been damaged during the shipping of the product. Anwar Mavany also stated that he did not have any receiving records for the basil shipments that he claimed had been returned by his customers pursuant to the recall. Instead, he showed the investigator notes that he claimed documented the various shipments from Majestic's customers returning the recalled basil.

Anwar Mavany also stated in his August 17, 2005 affidavit that the two customers for whom he did not provide recall letters to the investigator on August 11, 2005 [redacted] of [redacted] and [redacted] had been verbally notified of the recall and had given the recalled basil to Majestic's drivers "on or about 7/11/05" during other deliveries. He further stated that "[a]ll of the product was retrieved [from those two customers,]" but he did not "have records of exactly how much was retrieved from those two customers."

FDA investigators contacted each of the five companies that Anwar Mavany claimed had received the basil imported under [redacted] and been notified of the recall. [redacted] and [redacted] both acknowledge purchasing and receiving bags of basil from Majestic. However, they both told the investigator that they had not been contacted by Majestic about a recall of the basil, contrary to Anwar Mavany's statement in his August 17, 2005 affidavit. Moreover, both of the companies informed the investigator that all of the basil they had purchased from Majestic had been sold to their customers. Therefore, contrary to Anwar Mavany's claim in his August 17, 2005 affidavit, neither [redacted]or [redacted] returned basil to Majestic pursuant to a recall.

With respect to the three customers whom Anwar Mavany claimed to have faxed recall letters, the FDA investigator was informed by each of these customers that they had not received a telephone call or a letter from Majestic concerning a recall of the basil. In fact, one of the customers,[redacted] informed the investigator that it had not purchased any basil from Majestic for over one and one-half years. Another of the customers, [redacted] stated that while it had returned [redacted] bags of basil to Majestic, the reason was not a recall. Instead, the basil was infested with insects.

As the importer of record, it is your responsibility to ensure that imported products meet all requirements of the Act and the regulations promulgated there under, which include holding the product intact until it is released by FDA. Your firm also has an on going responsibility to ensure that all import brokers, consignees and Qthers working on your behalf hold the imported product intact until such time as FDA releases it or authorizes it to be exported or destroyed. We remind you that introduction into or receipt in interstate commerce of any article that is adulterated or misbranded is a violation of the Act and may result in regulatory action without further notice such as seizure, detention without physical examination of shipments, debarment, injunction and prosecution. In addition, failure to promptly correct this situation and prevent future premature distribution of imported products may result in requiring that future shipments be held in secured storage. Secured storage will be under the supervision and direction of the U.S. Customs Border Protection, such as in a bonded warehouse. You will be responsible for all costs incurred in secured storage.

We request in writing within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct the violation, including an explanation of each step being taken to prevent the recurrence of the violation, as well as steps you have taken to improve your recall system.

If you have questions or a need for clarification regarding any issue in this letter, you may contact Compliance Officer Daniel Solis at (310)971-2356.

Your written reply should be addressed to:

U.S . Food and Drug Administration
Attn: J. Lawrence Stevens
Director, Imports Operations Branch.
222 West 6th Street, Suite 700
San Pedro, CA 90731

Sincerely,

/S/

Alonza E. Cruse
District Director