TOPICAL SKIN PROTECTANT

File: 970101_sep96_decls15_0001.txt
Page: 0001
Total Pages: 1

Subject: TOPICAL SKIN PROTECTANT                                         

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: INFORMATION PAPERS                                                                              

Document Number:          1

Folder Seq  #:         33











                                                          DASG-HCL-P
                                                           15 Jan 91


                                     INFORMATION PAPER


            SUBJECT: Topical Skin Protectant


            1. Purpose. To provide update on procurement of Topical Skin
            Protectant (TSP).
            2. Fa@ts.

                a. The first shipment of 144K C-ounce bottles of TSP Was
            delivered to Defense Depot Mechanicsburg on Thursday, 10 Jan 91
            for shipment via Dover to the 47th MEDS014. on Friday, 11 Jan 91
            the FDA notified USAMMDA by phone that the TSP being produced
            differed from the original test samples approved by the FDA.
            USAMMDA requested DASG-HCL hold the shipment within CONUS until
            the issue can be resolved. The first shipment is being held at
            Dover and a second shipment of 72K bottles is also on hold at
            Mechanicsburg as of 14 Jan 91.
                b. Both quantitative and qualitative concerns have been
            raised by the results of the testing on the TSP currently being
            produced. The differences raise questions on whether the TSP
            being produced will provide the same protection as that originally
            tested and there are concerns about product safety.
                c. As of Saturday, 5 Jan 91, the FDA has assumed all
            responsibility for the qulitative analysis (QA) of production in
            lieu of the QA testing done by a contractor for the manufacturer.

                d. On 12 Jan 91 samples from the production line were sent to
            the Institute of Chemical Defense at Aberdeen Proving Grounds for
            animal safety and efficacy testing. This testing began on
            15 Jan 91. Human safety studies (patch test) will also be
            conducted to ensure product safety (no topical skin reactions).
e two weeks
            to thirty days.
                e. Although it is not known what caused the change in the end
            item being produced, it is speculated that unvalidated analytical
            testing methods or new equipment brought on to meet production
            requirements may have played a role.

                f. Production has been stopped by USAMMRDC. Further
            scheduled deliveries are being put on hold at the manufacturing
            plant to avoid extended storage constraints on Mechanicsburg.


                               Mrs. Gertrude Francoise/(703) 756-8077

Document 1 f:/Week-36/BX003205/INFORMATION PAPERS/topical skin protectant:12249609312116
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = INFORMATION PAPERS
Folder Seq # = 33
Subject = TOPICAL SKIN PROTECTANT
Document Seq # = 1
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 24-DEC-1996