| Public Health Service |
Chicago District |
Departmentof Health and Human Services
March 25, 2004
WARNING LETTER
CHI-5-04
CERTIFIED MAIL
Mr. Miles D. White
Chairman& CEO
Abbott Laboratories, Inc.
One Abbott Park Road, Bldg AP6
Abbott Park, IL 60064
Dear Mr. White:
During inspections of your firm’s Hospital Products Division (Abbott HPD),located at 600 N. Field Drive, Lake Forest, IL, from April 22 to May 1, 2003,and from May 28 to September 2, 2003, United States Food and Drug Administration(FDA) investigators determined that your firm manufactures intravenous administrationsets. These products are devices as defined by Section 201 (h) of the FederalFood, Drug, and Cosmetic Act (the Act).
These inspections revealed that these devices are adulterated within the meaningof Section 501(h) of the Act, in that the methods used in, or the facilitiesor controls used for manufacturing, packing, storage, or installation are notin conformance with the Quality System Regulation (QSR), Title 21, Code of FederalRegulations (CFR), Part 820, as follows:
1. Your firm’s management with executive responsibility failed to ensurethat the quality policy was understood, implemented, and maintained at all levelsof the organization as required by 21 CFR 820.22. For example, from May 2 toMay 19, 2003, Abbott HPD continued to distribute the following products manufacturedwith [redacted] that Abbott HPD [redacted] (FDA 483 issued 09/02/2003, Item#1):
Lifeshield Latex-Free Macrobore Ext. Set, 7 Inch with Clave and Option-Lok,List #120940402, Lot #021045H
Lifeshield Latex-Free Secondary LV. Set, Convertible Pin, 32 inch Piggybackwith Option-Lok, List #1119530448, Lot #010804W
Lifeshield Latex-Free Primary IV Set Convertible Pin, 100 inch, List #119620478. Lot # 910574W
Lifeshield Latex-Fee Primary IV Set, Convertible Pin, 100 Inch, List #119650468, Lot # 010424W
Latex-Free Primary IV Set, Convertible Pin, 80 Inch, List # 049680478,Lot # 921204W
Lifeshield Latex Free Primary IV Plumset, Convertible Pin, 104 Inch, List# 120300412, Lot #941485H
Lifeshield Latex Fm Primary IV Set, Convertible Pin, 100 Inch, List #I1196200478Lot # 900584W
Lifeshield Latex Fret Secondary IV Set, Convertible Pin, 32 Inch, List#I 19540448, Lot # 860994W
Lifeshield Latex Free Primary IV Set, Convertible Pin, 100 Inch, List #119620478, Lot # 911034W
Lifeshield Latex Free Primary IV Set, Convertible Pin, 100 ID&, List#I 19650468, Lot # 020984W
2. Your firm failed to revalidate the manufacturing and sterilization processwhere appropriate as required by 21 CFR 820.75(c). For example, on December19, 2001, Abbott HPD began using [redacted] to manufacture drip chambers for[redacted] IV set products. Abbott HPD's specifications required [redacted]to be used in manufacturing IV set products [redacted] Abbott HPD had no documentationof validation for this new process change. (FDA 483 issued 05/01/2003, Item#1)
3. Your firm failed to maintain procedures for implementing corrective andpreventive action as required by 21 CFR 820.100(a). [redacted] Abbott had nodocumentation that shows they tool follow-up action in response to the [redacted](FDA 483 issued 05/01/2003, Items #4-6)
4. Your firm failed to maintain procedures to ensure all purchased, or otherwisereceived, product conforms to specifications as required by 21 CFR 820.50, Forexample, Abbott’s specifications require [redacted] to be used to manufacture[redacted] drip chambers. [redacted] entitled, [redacted] requires, "Verificationthat material meets specifications, and was produced in accordance with indicatedmaterial and process specifications.” After December 19, 2001, Abbott receivedcertificates of analysis (labeled as Certification Records) for [redacted].Despite receipt of the [redacted] certificates of analysis, Abbott used the[redacted] to manufacture [redacted] drip chambers. (FDA 483 issued 05/01/2003,Item #2)
5. Your firm failed to ensure that all personnel are adequately trained toperform their assigned responsibilities as required by 21 CFR 820.25(b). Forexample, the Supplier Quality Assurance Engineering Project Specialist &Supervisor (performs audits of Abbott HPD's suppliers) had not been trainedon the following required procedures for Abbott supplier auditors: [redacted](FDA 483 issued 05/01/2003, Item #7)
6. Your firm failed to establish adequate procedures for quality audits asrequired by 21 CFR 820.22. For example, the [redacted] include specific timeframes for conducting internal audits. Both these procedures stated that qualityaudits be conducted at defined intervals and at a sufficient frequency. However,the procedures did not define the interval or frequency. ( FDA 483 issued 05/01/2003,Item #8)
This letter is not intended to be an all-inclusive list of deficiencies atyour facility. It is your responsibility to ensure adherence to each requirementof the Act and regulations. Federal agencies are advised of the issuance ofall Warning Letters about devices so that they may take this information intoaccount when considering the award of contracts.
You should take prompt action to correct these deviations and to establishprocedures to prevent their recurrence. Failure to promptly correct these deviationsmay result in regulatory action being initiated by FDA without further notice.These actions include, but are not limited to, seizure, injunction, and/or civilpenalties. Additionally, no premarket submissions for Class III devices to whichthe QS regulation deficiencies are reasonably related,will be cleared or approveduntil the violations have been corrected. Also, no requests for Certificatesfor Products for Export will be approved until the violations related to thesubject devices have been corrected and verified.
We acknowledge receipt of your firm’s responses to the Forms FDA-483,dated September 2 and May 1, 2003. Your firm’s responses include lettersdated September 18, August 4, June 10, July 28, May 29, May 23, and May 21,2003; a teleconference dated May 12, 2003; and meetings dated July 23 and May2, 2003. Although it appears from your responses that you are working towardcorrecting the deviations noted at your firm, you must adequately implementand maintain each corrective action to ensure its effectiveness. We will verifythe adequacy of your corrective actions during a subsequent inspection.
Please notify this office, in writing, within fifteen (15) working days ofreceipt of this letter of the specific steps you have taken to correct the notedviolations, including (1) the time frames within which the corrections willbe completed (2) any documentation indicating that the corrections have beenachieved, and (3) an explanation of each step being taken to identify and makecorrections to any underlying systems problems necessary to assure that similarviolations will not occur.
Your response should be sent to Michael Lang, Compliance Officer, Food andDrug Administration, at 550 West Jackson Blvd., 15th Floor, Chicago, lL, 60661-5716.If you have any questions regarding this letter, please contact Mr. Lang at(312) 596-4225.
Sincerely,
/s/
Richard Harrison
Acting District Director
