March 26, 2009

Merck Gets Warning Letter from FDA Over Shoddy Manufacturing Practises

Who says vaccines are dangerous? The FDA says so!
(Thanks to Shelley for the news.)

The following is an excerpt from FDA's letter, highlights mine. Blanks are words that have been redacted.

April 28, 2008

From: Dept. of Health and Human Services, FDA
To: Merck and Company, Inc.

The FDA investigators documented significant deviations from current good manufacturing practice in the manufacture of vaccines and drugs, including PedvaxHIB, Recombivax HB, ProQuad, Gardasil, VAQTA, and ComVax.

Current Good Manufacturing Practice Deficiencies

1d. Product lots that failed the initial visual inspection for critical defects were not thoroughly investigated. For example, MMR _____ and _____ failed the critical defect category for _____ and no investigations were performed. These lots were subsequently distributed.

[Note this: They knowingly distributed defective lots.]

3. Your firm failed to assure that there are 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.

4. You failed to assure that equipment used in the manufacture, processing, packing and holding of a drug product is calibrated, inspected, or checked according to a written program designed to assure proper performance. Specifically, a set of control samples representing defect types are examined by the automated inspection equipment prior to beginning each inspection process. The reject set testing allows high rates of known rejects to be accepted by the equipment.

[Comment by Shelley: "This is unbelievable. It states clearly Merck did not perform adequate calibration of equipment while processing Gardasil. I worked as a lab technician for years and if a machine is not calibrated correctly, it does not submit the correct dosage in the vial. Calibration of equipment is very serious in the mass production of a product. Plus they did not log the information concerning the lot numbers for some of the batches. How will the CDC be able to link all the information correctly?"]

6a. During review of atypical process reports (APR’s), QA release personnel may edit the number of occurrences calculated by the software. (!!!)

Failure Investigations

2a. You failed to quarantine numerous process intermediates associated with the use of filter membranes that were identified to cause foaming during filtration. This foaming was found to be associated with leaching of _____ into process intermediates. These process intermediates were used to further manufacture MMR, PedvaxHIB, VAQTA, VARIVAX product lots.

2b. Your investigation into leaks discovered in the _____ during _____ recharge for lot _____ concluded that the leaks resulted from a small hole in the _____. Attached to the investigation was an unsigned and undated chronology of events, estimated to the second. This information was derived from a notebook maintained by the production operator. However, these pages from the notebook are no longer available.

Laboratory Controls

3. Laboratory controls do not include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure components and products conform to appropriate standards of identity, strength, quality and purity. For example, there has been no evaluation of the stability of measles, mumps and rubella drug components over the multiple year storage and use periods.

The deficiencies described in this letter are indicative of your quality control unit’s inability to fulfill its responsibility to assure the identity, strength, quality, and purity of your drug product and drug substance.

---

So, were they made to dump the defective lots? Nope! Their pals at the FDA just give them a slap on the wrist and they go ahead and ship these to your doctor to be injected into your child.

Read the full letter here.


See also:

Sri Lanka Halts Vaccination Drive After Girl's Death from Expired Vaccine

Vaccine Developer Would Not Vaccinate His Own Child


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