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Home My WebLink AboutApartment 8 - Complaints - 1 ELM COURT 11/14/1996 Town of North Andover a „ORTH 1 OFFICE OF �a o�' ,t o "• 0 COMMUNITY DEVELOPMENT AND SERVICES ° . To 146 Main Street „ Xo yx North Andover, Massachusetts 01845 �,9ppO,itp.Pa`1y WILLIAM J. SCO77 9SSACHUS�� 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, ! ,� Susan Ford, Health Inspector SF/cjp Enclosure BOARD OF APPEALS 688-9541 BUILDING 688-9545 CONSERVATION 688-9530 HEALTH 688-9540 PLANNING 688-9535 �r�SERVIC[S L � DEPARTMENT OF HEALTH &HUMAN SERVICES PUBLIC HEALTH SERVICE o a 7 FOOD AND DRUG ADMINISTRATION Winchester Engineering and Analytical Center 109 Holton Street, Winchester, MA 01890 Telephone: 617-72 9-5700 November 7 , 1996 Susan Ford, Health Inspector No. Andover Board of Health Town Hall Annex 146 Main Street No. Andover, MA 01845 Dear Ms. Ford: Sample No. : 97-779-734 Complaint No. : NWE-0561 Product: Infant Formula Dear Ms. Ford: 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 ' !3.0FF!CO3L M/'�l : ALIY : E 2 DEPARTMENT 1 7MAI - ;E$3oo HEALTH AND H _as P 536 27 p.B.MET ER PUBLIC HEALTH SE, _ America's MA sy• 6505339 FOOD AND DRUG ADMINISTRATION t lth �- u �® WINCHESTER ENGINEERING AND ANALYTICAL CENTER f POSTAGE AND FEES PAID 109 HOLTON STREET Emmo , U.S.DEPARTMENT OF H.H.S. WINCHESTER, MASSACHUSETTS 01890 r�t�p�.," HHS-396 OFFICIAL BUSINESS �l�� 0 PENALTY FOR PRIVATE USE,$300 O Susan Ford, Health Inspector No. Andover Board of Health F Town Hall Annex : ,>�'`� Fr 146 Main Street No. Andover, MA 01845 I 126 0184S_2434 &1 v S(P VICt/� DEPARTMENT OF HEALTH & HUMAN SERVICES PUBLIC HEALTH SERVICE 00, FOOD AND DRUG ADMINISTRATION Winchester Engineering and Analytical Center 109 Holton Street, Winchester, MA 01890 Telephone: 617-729-5700 November 7 , 1996 Susan Ford, Health Inspector No. Andover Board of Health Town Hall Annex 146 Main Street No. Andover, MA 01845 Dear Ms . Ford: Sample No. : 97-779-734 Complaint No. : NWE-0561 Product: Infant Formula Dear Ms. Ford: 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 '"FAX Date 10129196 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: Fax Phone 508 688-9542 REMARKS: ❑ Urgent ® For your review ❑ Reply ASAP ❑ Please Comment Lina, I 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 DATE: October 28, 1996 ADDRESS: 8 Elm Court PHONE: 508 682-3192 North Andover, MA 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 / 1,1117-1va la 1r",e- PUBLIC HEALTH SERVICE � � rn� 6-2/ FOOD AND DRUG ADMINISTRATION 2 NAME AND TITLE OF INDIVIDUAL 3 DATE 4.SAMPLE NUMBER LSK� 5 FIRM NAME 6.FIRM'S DEA NUMBER 7.FDA'S DEA NUMBER D 01:4� 17AF17A 8.NUMBER AND STREET 9.CITY AND STATE (Include Zip Code) / a�r� �1- 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 121 U.S C.374(c)]and/or Part F,Sub Part 3,Section 356(b)of The Public Health Service Act[42 U.'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.) 120 1174 e,19 bof�t.n a 5.��C' AMk 11.SAMPLES WERE 12 AMOUNT RECEIVED FOR SAMPLE 13.SIGNATURE(Person receiving payment for sample or PROVIDED AT NO CHARGE CASH ❑ BILLED person provi ' sample to FDA at no charge.) ❑ ❑ PURCHASED /V C ❑ VOUCHER ❑ CREDIT � ❑ BORROWED(To be returned) CARD 14 COLLECTOR'S NAME(Print or Type) 15 COLLECTOR'S TITLE(Print or Typer, 16.C LECTOR'S SIGNATURE FORM FDA 484(10/87) PREVIOUS EDITION MAY BE USED RECEIPT FOR SAMPLESPAGE 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 142 U.S.C.263d]is quoted in part below: "Section 356(b)In carrying out the purposes of subsection(a),the Secretary is authorized to- (2) ..�: (3) ...: (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 is not 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 121 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 " SAMPLE NO. AFFIDAVIT q _-77 _ �3 STATE OF COUNTY OF Before me, -,1,Irxz0a S. �,�/n ,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 .ScJ.Sli/7 a-ey in the county and State aforesaid,who, being duly sworn,deposes and says: /p /7k �G �J f�v•-ce yam b�'6v9h �rl/v mS- l�v� crlJ `lQ� 4Lo�'IavPG'1 �� uJr�� a�� /OCri�� 9 ® /u-6-al 7 -v n 7%2 7%9 �'c� r•�� uJaS' �� /YJ5'. ,1�c✓� v� a/SU 7� S7'1S. 1�o�C��r7 fIGG� 1120 0'7��7 7�1s .0,060IVctl AFFIANT'S SIGN RE AND TITLE FIRMV'S N.AAVfE AND ADDRESS(Inc ude ZIP Code) Subscribed and sworn to before me atQ�Q�1C"�l S� (City and State) this 3�day of ��/ 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,11, 1953;and P.L.96-88 effective Mav 4, 1980. FORM FDA 463a (4/83) PREVIOUS EDITIONS ARE OBSOLETE PACE OF PAGES. *U.S.Government Printina Office: 1991—281.802/23836 USE BEFORE DATE ON END Ready To Feed SHAKE VERY WELL • DO NOT p ' Do Not Add Water 1 INGREDIENTS:86°k WATER,4.5°k SUGAR(SUCROSE), Breast milk is best for 2.3%CASEIN HYDROLYSATE(ENZYMATICALLY HYDRO medical conditions e al 1 LYZED AND CHARCOAL TREATED),2.2%MODIFIED TAPIOCA Alimentum is formil I doe, 1 r ® STARCH,1.9%FRACTIONATED COCONUT OIL(MEDIUM- he specified by yoi ritionti , ° SOY needs.It is a nut:th seven it, y r CHAIN TRIGLYCERIDES),1.5%SAFFLOWER OIL,0.4/° protein maldiy i OIL,0.2%CALCIUM CITRATE,0. providesboll1%CARRAGEENAN,CALCIUM and childrenw, p pr PHOSPHATE DIBASIC,POTASSIUM PHOSPHATE DIBASIC, intact protein,olysate),to virtually 'ants , r ASCORBIC ACID,CALCIUM HYDROXIDE,POTASSIUM CHLO- tion.Aliment rp 1 RIDE,MAGNESIUM CHLORIDE,SODIUM CHLORIDE,L-CYS- (casein hydr .dily digested and at 1 1 TINE DIHYDROCHLORIDE,POTASSIUM CITRATE,L-TYROSINE, ty,and a rea,entum is specified for I CHOLINE CHLORIDE,L-TRYPTOPHAN,FERROUS SULFATE, When Alim,llow your doctor's instruL, nici 1 TAURINE,m-INOSITOL,ALPHA-T000PHERYLACETATE,ZINC needs,fr'a DIRECTED BY YOUR 00E 1 (t' SULFATE,L-CARNITINE,NIACINAMIDE,CALCIUM PANTO USE y To Feed formula,if mixed v, nal rf IRON s THENATE,VITAMIN A PALMITATE,CUPRIC SULFATE,THIA- Reae provide proper nutrition,and n �1 MINE CHLORIDE HYDROCHLORIDE,RIBOFLAVIN,PYRIDOX not A feedings could cause illness. � 11►11' INE HYDROCHLORIDE,MANGANESE SULFATE,FOLIC ACID, Sul.1RECTIONS FOR PREPARATION,I I�p POTASSIUM IODIDE,PHYLLOOUINONE,BIOTIN,SODIUM D Boil bottles,nipples and rings too r 0 R U SELENITE,VITAMIN D3 AND CYANOCOBALAMIN. i ,' then cool. IN`I� 5 FL OZ PROVIDES 100 Cal;1 LITER PROVIDES 676 Cal. '2.Rinse can lid and shake very well. 1 1`J NUTRIENTS: PER 100 Cal / clean punch-type opener. pRp� ERGS PROTEIN EQUIVALENT 5.54 g 3.Pour formula into bottles(or cup).F Cr 1 5FAT .54 g and rings,and feed.Discard unus& =1 Y 10.2 g ESN N p 0 A For CARBOHYDRATE 110 g remaining in bottle(or cup)after fee S r. 4 PR0 meeting LINOLEICACID 1600 mg VITAMINS: 300 IU Z 1 Special VITAMIN A 45 ILI VITAMIN D nutritional VITAMIN E 3.0 IU g �1 F VITAMIN K 15 mi" ;g Cr 9 needs THIAMIN(VIT.B1) 60 mi .,g � =1 RIBOFLAVIN(VIT.B2) 60 m ,cg _ =1 VITAMIN Be 0.45 v .ncg Important:Do not store at extreme to VITAMIN B12 Store unopened cans at cool temper - a 1 # FNIACIN OLIC ACID FOLACIN) 1350 15 r ��g formula in bottles not used immedi mperatures. ( opened can(covered)should be s' a 1 PANTOTHENIC ACID 750 is ncg refrigerator and used within 48 hr ,itures. 1 BIOTIN 4.5 r .ig ately and i VITAMIN C(ASCORBIC ACID) 9.0 n ,yg Warning:Never use a microwave d in 1 CHOLINE 8 r ng or warm formula.Serious burns r ore ore 1 O LINE 5 r Note:Ready To Feed formula alit, irs.even to prepare 1 MINERALS: in use:1)Fill one bottle at feed` m n result. 1 CALCIUM 105 � � several bottles for a dayteed fee s for flexibility 1 PHOSPHORUS 75 mg Because of the special nutr?' time,or 2)fill 1 MAGNESIUM 7.5 mg tics of Alimentum,it does r IRON 1.8 mg milk or soy formulas.Sh-, ' 0.75 mg proper blending. I characteris ZINC ik or taste like ' + �'� MANGANESE 30 mcg COPPER 75 mcg �I�r well to assure TM 15 mcg IODINE SODIUM 44 mg 1 118 mg POTASSIUM 80 1 CHLORIDE mg t v, 01995 Ross ROSS PRODUCTS DIVISION 1 ABBOTT LABORATORIES 7007� PEDIATRICS 1 OT (946 mQ COLUMBUS, OHIO 43215-1724 0