Wednesday, May 5, 2010

McNEIL Children's Drugs FDA Recall: Camp 'Runamuck' DETAILS Explained For You By Rev Barbara Sexton "The Biblical Biochemist-Where Science Meets the Cross"

     Oh boy.  Things are MUCH WORSE than they appeared at first blush with the recent McNeil Children's Drugs Recall.   From the FDA Inspection Report at the McNeil plant in Fort Washington, PA,  it has become obvious that McNeil's quality control problems are SEVERE.  According to the FDA field inspection reports, McNeil KNOWINGLY used raw materials that they KNEW were contaminated with BACTERIA.  This, dear Readers, is simply unconscionable.  Here are the highlights of the Inspection Report. MY TAKE IS IN CAPS, followed by the official FDA "Observations".
1)  GRAM NEGATIVE ORGANISMS (BACTERIA) FOUND IN TYLENOL RAW  MATERIALS "The responsibilities and procedures applicable to the quality control unit are not fully followed.
2)  MCNEIL HAS LITTLE OR NO QUALITY CONTROL PROCEDURES AND DOES NOT CONFORM TO CGMP'S ('CURRENT GOOD MANUFACTURING PRACTICES') "There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess." MORE SPECIFICALLY: "It (McNeil)  does not maintain adequate laboratory facilities or e stmg an approval (or rejection) of components and drug products; it neglects review and approval of validation protocols regarding changes in product processes and equipment to determine when revalidation is or should be warranted; it is default in investigations, tracking, trending and maintenance of consumer complaint follow-up; and it lacks trending ofproducts, components (i.e., water), and complaints to demonStrate a broad perspective to assure plant conformance with CGMPs."
3)BAD MIXING MANUFACTURING PRACTICES "Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity."
4) NO WRITTEN QUALITY CONTROL RECORDS DURING MANUFACTURING (NO IN-LINE TESTING) "Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."
5) NO CUSTOMER COMPLAINT FILES/CORRECTIVE ACTIONS/RESPONSE FOR COMPLAINTS OF PRODUCT WITH  FOREIGN MATERIAL, PARTICULATE MATTER AND/OR CONTAMINATION. "Written production and process control procedures are not followed in the execution ofproduction and process control functions"
6) NO ASSURANCE OR INVESTIGATION OF QUALITY, PURITY, ETC FOR FINISHED PRODUCTS DESTINED TO BE ADMINISTERED TO CHILDREN WITH KNOWN RAW MATERIAL BACTERIAL CONTAMINATION.  MCNEIL RELEASED FOR SALE THESE PRODUCTS ANYWAY! "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
7) NO GMP (GOOD MANUFACTURING PRACTICES) TRAINING...NOT MANY GMP'S FOR THAT MATTER, EITHER ACCORDING TO THESE FDA OBSERVATIONS. "GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them."
8) NO CUSTOMER COMPLAINT FILES "Procedures describing the handling of all written and oral complaints regarding a drug product are not followed"
9) NO SECOND PERSON 'SIGNING OFF' ON MANUFACTURING CHECKLISTS (IF MCNEIL HAD CHECKLISTS, THAT IS)  "Each container of component dispensed to manufacturing is not examined by a second person to assure that the weight or measure is correct as stated in the batch records."
10) BAD LABELING AND LABELING PRACTICES  "Strict control is not exercised over labeling issued for use in drug product labeling operations."
11) NO STABILITY TESTING (WHICH KIND OF RENDERS MY 'TESTING OF RETAINED SAMPLES SOMEWHAT MOOT) "There is no written testing program designed to assess the stability characteristics of drug products."
12) NO LAB PRODUCT QUALITY STANDARDS (SPECIFICATIONS, AND SOP'S-STANDARD OPERATING PROCEDURES) TO ASSURE BATCH-TO-BATCH CONSISTENCY  AS JUDGED AGAINST 'APPROVED SAMPLES' OF A GIVEN PRODUCT) "Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity."
13) BAD LAMINAR FLOW HOODS/FILTERS, NO OR INSUFFICIENT MICRO WORK, DIRT/LACK OF CLEANING/NO LOG IN RAW MATERIAL WEIGH AREA, DUST, DIRT, DEBRIS, DUCT TAPE, "GREY/BROWN DUST ON INCUBATOR BOTTOMS, BAD ASEPTIC TECHNIQUE BY MICROBIOLOGISTS AND MORE  "Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit."
14) LAB REFRIGERATORS NOT CALIBRATED PROPERLY Laboratory records do not include complete records of the periodic calibration of laboratory instruments, gauges, and recording devices.
15) SOP (STANDARD OPERATING PROCEDURE) PROBLEMS WITH MICRO SAMPLING SWABS FOR CLEANED EQUIP, LACK OF APPROPRIATE COLONY-COUNTING STANDARDS, ETC. "Written specifications for laboratory controls do not include a description of the sampling procedures used."
16) IGNORING THE QUALITY CONTROL RULE TO 'TAKE YOUR OWN SAMPLES AND USE APPROPRIATE SAMPLING METHOD(S)', MCNEIL HAD RAW MATERIAL MANUFACTURERS PULL (INSUFFICIENT) SAMPLES FOR THEM "Samples taken of in-process materials for determination of conformance to specifications are not representative.
17)WHAT'S WHAT AT MCNEIL? LEAKING BAGS, TOO. "Each lot of components,was not appropriately identified as to its status in terms of being quarantined, approved or rejected."
18) NO MICRO TESTING ON WATER USED "Components are not microscopically examined when appropriate."
19) NO CLEANING & MORE 'GREY-BROWN DUST' "Records are not kept for the maintenance and inspection of equipment"
20) LACK OF CHECKLIST/SIGN-OFF'S "The persons double-checkng the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log"
 Read it  first hand here:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM210772.pdf
 The main page for the McNeil Tylenol, Motrin, Zyrtec and recall is found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210441.htm
     I have many years of first hand experience working with FDA inspectors breathing down my neck (they literally 'dog you' every minute of the day)...and God Bless them for doing it!  Here is an example of a very valuable service the FDA performs on behalf of the public!  I don't always think so highly of them, but in this case, the FDA is 'dead on'. 
     I'm sorry to say this, but at this point I would be skeptical about ANYTHING McNeil has to say on it's own behalf,  unless and until their claims are fully verified by repeated, independent testing.
      The FDA will need to do what they do in cases like this, which will likely include the following, based on what I know about these things:
---Test every 'raw material' in house now for microbial contamination and to see if it meets specifications chemically
---Test every in-line product and final products in house now and test as above.
---Test all 'retained samples' of raw materials, in-line products and final products and all packaging, as above, going back as many years as the FDA Inspectors see fit.
---Have independent labs repeat all FDA testing
---Mandate that McNeil have independent testing done on all applicable samples also by 2+ independent labs.
      I think you get the idea.  It will be a major job.  Your job is to not use any of these products until further notice.  I will update you as appropriate.
     It's difficult to not 'stand in judgment' of the shoddy QC practices and other practices exhibited by McNeil.  God only knows what they've been thinking, to attempt to 'get away' with things as they are and have been.
     Don't forget that many pets are given 'human' medications, too.  God forbid that a child, adult or beloved pet has been harmed in any way by the negligence and lack of caring demonstrated by McNeil. 
With prayers for your health and safety with a plea for McNeil to 'come clean' on all of this--
I am,
Rev Barbara Sexton
"The Biblical Biochemist-Where Science Meets the Cross"
http://www.dearoneshealingministry.blogspot.com/

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