of these swab findings and to suggest sampling procedure of any other products.

Charles B. Thorne, Supervisory Investigator, Newark District was contacted on February 11, 1974, for the purpose of discusing the situation. Mr. Thorne stated that samples of 10 lots had been submitted to National Center for Antibiotics Analysis (HFD-430) on January 18, 1974, but had not obtained the results as yet.

Bernard Arret, Deputy Director for the National Center of Analysis was contacted on February 11, 1974, and he informed us that he had just completed the analysis of 11 samples of Erythromycin Sulfate Tablets packaged by Mylan Pharmaceuticals. He stated that 2 or 3 lots exceeded 0.5 unit penicillin contamination tolerance allowed under Section 133.11. Another 2 or 3 were negative, with the remaining samples showing amounts between 0 and 0.5 units. He said the results had not been checked or signed off by him as yet.

The situation was reported to Mr. Apodaca who contacted Mr. Robinson.
A meeting was arranged that day to discuss the problem.

Mr. Robinson stated during the conference that 11 lots offered for certification had been found to contain varying degrees of ampicillin contamination. One lot was Wyeth Laboratories, the other 10 were E.R. Squibb & Sons.

The analytical procedure used was comparatively new. He said the previous method using amyl acetate was able to obtain pencilllin contamination only, but the revised direct method was able to obtain ampicillin as well.

He said that only 2 lots (1-Wyeth, 1-Squibb) were found to contain in excess of 1 unit contamination.

Investigation by the districts had traced the contamination to the raw material manufactured by Pierrel, in Italy. Another possible source of contamination was Saipan, Portugal, but this was presumptive.

The tablets were all manufactured by Mylan Pharmaceuticals.

Mr. Robinson stated that Mr. Sorensen had collected approximately 40 samples of finished products and bulk material at Mylan. lle also informed us that a meeting with Mylan Pharmaceuticals had been held on 2/8/74.

Mr. Robinson was asked what Certification Services was doing to follow-up on this problem. He stated that he was working in close communication with Baltimore District in obtaining a list of all firms receiving the suspect material.

He said that 5 of the 11 batches found to be contaminated would be refused certification, the other lots would be held pending further investigation.

Mr. Apodaca informed Mr. Robinson that because of the fluctuating results obtained, and the fact that such penicillin contamination was not evenly spread through these lots, that all the lots would be suspect regardless of analytical findings as well as those that may already have been certified.

HFD-145 will be fully responsible for directing follow-up and Mr. Robinson said he would keep Division of Regulatory Operations informed of the progress of the investigation.

This is to confirm the talmhora conversation of February 26, 1975 between you and fir. Timothy Settek of my staff fevition you or another representative of your comany to attend a meeting to discuss the problem of insulin dosage errors caused by variations in the design of insulin syringes and the mixing of different insulins.

We are also inviting other interested representatives of the drun and device industry to this preting which vilī be held on March 7, 17 at 10:00 a.m. in Room 1473 of Fetural Office Quilding No. S.., Herinnter, B.C.

We are happy that you will be with us on March 7 and look forvar! to seeing you then.

TOottek:jkb 2/27/74

Sincerely,

David 1. Link, detine Pirreter
Wical wiers and
Olanestic Products

The attached letter just came to light. An anonymous ex-employee alleges

that "many problems have arisen" at Squibb since the firm reduced its quality assurance force.

This is being forwarded to you for whatever follow-up you deem appropriate.

Encl: Incoming letter

CC:✔HFA-226

HFD-300 R/F

DRO

Init. by: RApodaca 3/12/74

PSheeler:dla:3/12/74

Philip Sheeler

BD

Jan. 20, 1973.

Gentlemen:

In reference to the Quality Assurance Dept. of E. R. Squibb & Sons, of New Brunswick, N. J. I take to this writing.

It has been a standard practice, set by the Food and Drug Act, to have Quality Assurance Inspectors check every product, manufactured and packaged by the company.

This has been the procedure until two years ago, when Q. A. Dept. cut their budget by eliminating six Inspectors, that were checking the products in Pkg., and Pen. Depts.

I understand many problems have arisen, since this practice has been discontinued, Is there some way to have this reinstated, as I as well as many others, are daily users of Squibb products, and would like to feel that we can trust their medicines to be of good quality and be assured that there won't be foreign matter or glass mixed in the product.

I regret that I am unable to state my name, but I must withhold my identity to prevent any embarrassment to my friends and associates.