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Home My WebLink AboutMiscellaneous - 8 ELM COURT 4/30/201800 tri 0 0 (t Town of North Andover a NORTH OFFICE OF 3?0`�`'`0 �oL COMMUNITY DEVELOPMENT AND SERVICES p . - 146 Main Street North Andover, Massachusetts 01845 WILLIAM J. SCOTT Director November 14, 1996 Megan Donegan 8 Elm Ct. North Andover, MA 01845 Dear Ms. Donegan: As requested, I am forwarding you a copy of the report received concerning your complaint. For your information, the Board of Health will not be requesting the return of this material to our office. If I can be of further assistance, please do not hesitate to cal the office. Sincerely, �,yr I S�Ford Health Inspector SF/cjp Enclosure _ BOARD OF APPEALS 688-9541 BUILDING 688-9545 CONSERVATION 688-9530 HEALTH 688-9540 PLANNING 688-9535 DEPARTMENT OF HEALTH & HUMAN SERVICES Susan Ford, Health Inspector No. Andover Board of Health Town Hall Annex 146 Main Street No. Andover, MA 01845 Dear Ms. Ford: Dear Ms. Ford: PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Winchester Engineering and Analytical Center 109 Holton Street, Winchester, MA 01890 Telephone: 617-729-5700 November 7, 1996 Sample No.: 97-779-734 Complaint No.: NWE-0561 Product: Infant Formula We have examined the article you furnished to the New England District Office in connection with the complaint you received from: Megan Donegan 8 Elm Ct. No. Andover, MA Our examination revealed the following: No foreign material was found in the one (1) previously - opened can of Ross Pediatrics Alimentum. The consumer's exhibit was a grey -colored (15mm x 6mm x 3mm) clump consisting of paper fibers and fat/grease/oil. The remaining portion of the sample consists of one (1) empty can and two (2) petri dishes containing the filtered product and the consumer's exhibit. If you wish this returned to you, please request it by December 6, 1996. If we do not hear from you by that date, the articles will be destroyed. No reply is necessary if you do not desire return of this material. Very truly yours, Martin J. Finkelson Director, Analytical Branch N � o C2 ' o O Z o U Ld lr� `ccz Z W LU / w Q w / ZO1:DU) C9 Zw�� za {LZ� ¢: �UVJ� Ncr � Q C:, LU Z W m 0 WVOw J ¢-i GQ.QIII m0 U OX CL L'0 ZQ�" 3: < ,LZ O a S- o O L U r N tc$ Q. N N S LO C d' i+4- CO O —r O tts ft X a--) Q (v O N N 5;- � L ^ Q a-) i '0 970 N 0) L > -- > 00— C O a= «S N 3� :3 O O c::r O NZh---+Z co r DEPARTMENT OF HEALTH & HUMAN SERVICES Zee -,x J whra a Susan Ford, Health Inspector No. Andover Board of Health Town Hall Annex 146 Main Street No. Andover, MA 01845 Dear Ms. Ford: Dear Ms. Ford: PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION Winchester Engineering and Analytical Center 109 Holton Street, Winchester, MA 01890 Telephone: 617-729-5700 November 7, 1996 Sample No.: 97-779-734 Complaint No.: NWE-0561 Product: Infant Formula We have examined the article you furnished to the New England District Office in connection with the complaint you received from: Megan Donegan 8 Elm Ct. No. Andover, MA Our examination revealed the following: No foreign material was found in the one (1) previously - opened can of Ross Pediatrics Alimentum. The consumer's exhibit was a grey -colored (15mm x 6mm x 3mm) clump consisting of paper fibers and fat/grease/oil. The remaining portion of the sample consists of one (1) empty can and two (2) petri dishes containing the filtered product and the consumer's exhibit. If you wish this returned to you, please request it by December 6, 1996. If we do not hear from you by that date, the articles will be destroyed. No reply is necessary if you do not desire return of this material. Very truly yours, Martin J. Finkelson Director, Analytical Branch 3 A' �rAX Date 10/29/96 Number of pages including cover sheet TO: Lina Cicchetto FROM: Susan Ford, Health FDA Inspector North Andover Board of Health Town Hall Annex 146 Main Street Phone 617 279-1675 ext 188 North Andover, MA 01845 Fax Phone 617 279-1687 Phone 508 688-9540 CC: 1 Fax Phone 508 688-9542 IREMARKS: ❑ Urgent ® For your review ❑ Reply ASAP ❑ Please Comment Lina, am sending you the complaint information you requested regarding the baby formula. Please see attached. If possible, please have the investigator inform me about their actions so I may complete and close my file. Thank You for your assistance COMPLAINT FORM COMPLAINTANT: Megan Donegan ADDRESS: 8 Elm Court North Andover, MA DATE: October 28, 1996 PHONE: 508 682-3192 COMPLAINT: The North Andover Board of Health received a phoned in complaint from Megan Donegan on the morning of 10/28/96. The complaint concerned a liquid baby formula which Ms. Donegan claims to have found a small black object floating on the top just as she opened it. The object to her appeared to be the size of rat feces and of similar consistency. She removed the object and placed it in a plastic bag and called the BOH to file a report. Upon request she brought the entire quart of formula and the foreign object in question to the North Andover Health Department where it remains in our refrigerator. In addition, the CVS in which the formula was purchased was notified of the possible contamination. They commenced a volunteer removal from the shelves all of the products which may be of concern until they hear from the authorities. PRODUCT: Alimentum, Protein Rich Hydrolysate formula, with iron Ready to feed PRODUCER: Ross- Pediatrics Abbott Lab Columbus, OH 43215-1724 ID: 20555RC 14:00:54 SIZE: Quart, can DATE PURCHASED: 10/23/96 LOCATION PURCHASED CVS Pharmacy Turnpike St., North Andover, MA 01845 DATE OPENED: 10/25/96 AMOUNT CONSUMED: None INTENDED CONSUMER 10 week old child DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. DISTRICT ADDRESS PHONE NUMBER PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION 2. NAME AND TITLE OF INDIVIDUAL 3. DATE 4. SAMPLE NUMBER i'ji ' Ins 7 - 7- 5. FIRM NAME 6. FIRM'S DEA NUMBER 7. FDA'S DEA NUMBER 8. NUMBER AND STREET 9. CITY AND STATE (Include Zip Code) 10. SAMPLES COLLECTED (Describe fully. List lot, serial, model numbers and other positive identification) The following samples were collected by the Food and Drug Administration and receipt is hereby acknowledged pursuant to Section 704(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374 (c)] and/or Part F, Sub Part 3, Section 356(b) of The Public Health Service Act 142 U.I-C. 263d] and/or 21 Code of Federal Regulations (CFR) 1307.02. Excerpts of these are quoted on the reverse of this form. (NOTE: If you bill FDA for the cost of the Sample(s) listed below, please attach a copy of this form to your bill.) a7��iyl�i�ir� �ioa e9-L.Gc,P G�ti iC' ,Foss •��1�/� T��G S / 4 T��1 �� G� - �� Baa Ab 16'6211, -79 -it 11. SAMPLES WERE Xz PROVIDED AT NO CHARGE 12. AMOUNT RECEIVED FOR SAMPLE 13. SIGNATURE (Person receiving payment forsample or Person provi ' sample to FDA at no charge.) ❑ PURCHASED ❑ CASH ❑ BILLED t/ � E] VOUCHER ❑CRE IT �--� "-- ❑ BORROWED (To be returned) CARD 14./COLLECTOR'S NAME (Paint or`Type) LECTOR'S TITLE (Print or Type 16. C LECTOR'S SIGNATURE 167:co '//%(�� /�i/'- �i/� �.�li' ror t vuioi I rrnt vivu�, tui 1 1U VVIAY tit U�ot U. RC%—r-i 1 rVK Z0AMF'Ltb PAGE OF PAGES Section 704(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(c)] is quoted below: "If the officer or employee making any such inspection of a factory, warehouse, or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained." Part F, Sub Part 3, Section 356(b) of The Public Health Service Act [42 U.S.C. 263d) isquoted in part below: "Section 356(b) In carrying out the purposes of subsection (a), the Secretary is authorized to - '(2) YYYt (3) lYYY (4) procure (by negotiation or otherwise) electronic products for research and testing purposes, and sell or otherwise dispose of such products." 21 Code of Federal Regulations 1307.02 is quoted below: "1307.02 Application of State law and other Federal law. Nothing in Parts 1301-1308, 1311, 1312, or 1316 of this chapter shall be construed as authorizing or permitting any person to do any act which such person isnot authorized or permitted.to do under other Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he desires to do such act nor shall compliance with such Parts be construed as compliance with other Federal or State laws unless expressly provided in such other laws." An agreement between the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) provides that in the event any samples of controlled drugs are collected by FDA representatives in the enforcement of the Federal Food, Drug, and Cosmetic Act, the FDA representative shall issue a receipt for such samples on FDA form FDA 484, RECEIPT FOR SAMPLES, in lieu of DEA form 400, to the owner, operator, or agent in charge of the premises. Report of analysis will be furnished only where samples meet the requirements of Section 704(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(d)) which is quoted below: "Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge." AFFIDAVIT SAMPLE NO. q 7,9 - _STATE STATE OF COUNTY OF Before me, a S .�o� �,� G� , an employee of the Department of Health and Human Services, Food and Drug Administration, designated by the Secretary, under authority of the Act of January 31, 1925, 43 Statutes at Large 803; Reorganization Plan No. IV, Secs. 12.15, effective June 30, 1940; Reorganization Plan No. 1 of 1953, Secs. 1-9, effective April 11, 1953; and P.L. 96-88, Sec. 509, 93 Statutes at Large 965 (20 U.S.C. 3508), effective May 4, 1980; to administer or take oaths, affirmations, and affidavits, personally appeared SL ---'S41-7 in the county and State aforesaid, who, being duly sworn, deposes and says: / Svsa Fa�d� flea /744 D4A— O / 2,-o had IP17O6-ec/Aa .Do1po/-7 J a17 Gi C �G� L!J/ 7 Y pr��r �✓ c/ � �e i /go o�� p�dv�f C f AFFIANT'S SIGN RE AND TITLE 1 IfiWVS NAME AND ADDRESS (Inc ude ZIP Code) /tJorf� �Frid peer /�va�' o� f�a b In 414 Subscribed and sworn to before me at A• Benda 1,jf/ Sf— (City and State) this day of �D�� 19 (Employ e's Signature) Employee of the Department of Health and Human services designated under Act of January 31, 1925, Reorganization Plan IV effective June 30. 1940; Reorganization Plan No. 1 of 1953, effective April:ll, 1953; and P.L. 96-88 effective Mav 4. 1980. rn ORA CLIA AC7_ -- rrstvtuus tUl I TUNS ARE OBSOLETE PATE OF PAGES. 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