Baxter Healthcare of Puerto Rico - September 9, 2010
Issue Date
Sep 09, 2010
Region
Southeast
Category
Drug
$117.00
Address 1
No. 250 Rd. 144
City
Jayuya
Zip/Postal Code
00664
Country
PR
Inspection Range
Jul 14, 2010 - Aug 26, 2010
Pages
5
First Observation
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
Specifically, there is no assurance that the criteria used for the evaluation and disposition of 15% Clinisol Sulfite Free (Amino Acid) Injection 500 ml; lot #P244269; Expiration date 10/2010 that was impacted by a failure event (broken damper) in filling line were adequate.
Investigator(s): Dayna I. Martinez and Brenda RiveraSpecifically, there is no assurance that the criteria used for the evaluation and disposition of 15% Clinisol Sulfite Free (Amino Acid) Injection 500 ml; lot #P244269; Expiration date 10/2010 that was impacted by a failure event (broken damper) in filling line were adequate.