TOPICAL SKIN PROTECTANT 15 JAN 91

File: 121096_sep96_decls8_0001.txt
Page: 0001
Total Pages: 1

Subject: TOPICAL SKIN PROTECTANT  15 JAN 91                              

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003203

Folder Title: TOPICAL SKIN PROTECTION                                                                         

Document Number:          1

Folder Seq  #:        109









                                                       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. Facts.

             a. The first shipment of 144K 4-ounce bottles of TSP was
         delivered to Defense Depot Mechanicsburg on Thursday, 10 Jan 91
         for shipment via Dover to the 47th MEDSOM. 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).
         The best estimates are that product acceptance may take two weeks
         to thirty days.

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/BX003203/TOPICAL SKIN PROTECTION/topical skin protectant 15 jan 91:1206961535499
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = TOPICAL SKIN PROTECTION
Folder Seq # = 109
Subject = TOPICAL SKIN PROTECTANT 15 JAN 91
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 = 06-DEC-1996