DEPARTMENT OF HEA LTH AND HUMAN SERVICES 

rooo A,\/O DR UG ADMINISTRATION 

OiS ' """'"' AOORESS AHO PH'-"C NUM8ER 

10903 New Hampshire Ave , Bldg71-5128 

Silver Spring, MD 20993- 0002 

240-402-8906 

o rabioins pecti onalcor r e spondence@ fda.hhs .gov 

DA'fE(S) OF IN SPECl10tl 

2/20/20 20-2/27/2020* FEINUMBfR 

3002638287 

N.W£ ~ mLEOI' IMOMCI.W. TO WHOM REPORT """'eo 

Mr. Adria n Bi r kett, Head of Operations FIRM NAME 

Millipore (U.K. l Ltd . 

STREET ADDRESS 

2 Fleming Road, Ki r kton Campus CllY, STAI t. ZIP COOE, COU"'m 

Livingston, West Lothian, EH54 7BN 

United Ki ngdom 

TYPE ESTA8L1SI-MENT INSPECTED 

Li censed Bulk (FFMU ) Blood Grouping 

Reagent ~anufacture r 

This document lists observations made by the FDA representativc(s) duringthe inspection ofyour facility. They are inspectional 

observations, and do not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an 

observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or 

action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. Ifyou have any 

questions, please contact FDAat the phone number and address above. 

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: 

OBSERVATION 1 

Lots of licensed products were released by the manufacturer prior to completion oftests for conformity 

with standards applicable to such product. 

Specifically, 

Complaint 2292851, received on 17Jan2020, Lot KNI1903, Anti-c FFMU, documented that the customer reported 

a sodium azide content of 0.03 % when the product labeling and Certificate of Analysis (CoA) states "Sodium 

Azide Content 0.1% w/v". Primary Production Investigation KNil 903 (RCA Task #2310298, closed on 

20Feb2020, reported that investigative testing as per K6H4) I task #'s 2297056 and 2306958 confirmed 

the customer's measurement of sodium azide solution concentration was correct. Document No. 00007239FM, 

Product Field Corrective Action (FCA) Assessment Form, dated 06Feb2020, reported: 

a. Sodium Azide content was not verified as part of lot release testing. 

b. QC testing confirmed the low sodium azide content was 0.0 I% w/v. 

c. The Product Evaluation Summary stated a product recall was required as the long term impact on performance 

of Anti-c FFMU, Lot No. KNI 1903 was unknown. 

SEE REVERSE 

OF THIS PAGE 

EMPt.OYEE(S) SIGl<AlVRE 

Prabhu P Ra ju, Investigator - Team 

Biol .._._ ogics 

=•T--

Ni rnmy Ma t hews, Investi gato r X o..•..-

-~-Z1-2Ca00l:fl21 

0,_TE ISSUED 

2/27/202 0 

FORM FDA "8) (09,VS) PR!lVIOI.S EDITI ON 0850U!T£ INSPECTJONALOBSERVATIOlliS PAGE 1 al 3 PAGES 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT ADORESS AND PtlO~ NUMBER 

10903 New Hampshire Ave , Bldg71-5128 

Silver Spring, MD 20993-0002 

240-402-8906 

orabioi nspectionalcorrespondence@fda.hhs.gov 

OATE(S) OF INSF£CTION 

2/20/2020-2/27/2020* 

FEI i'l'-"'8ER 

3002638287 

NAM~NIU Tin.E OF INDMOUAI. TOWHOM REPORT ISSIEl 

Mr . Adrian Birkett, Head of Operations 

FIRM NAME 

Milli pore (U . K . ) Ltd . 

STREET ACORESS 

2 Fleming Road, Kirkton Campus 

CITY, STATf, ZIP CODE, COUNTRY 

Livingston, west Lothian, EH54 7BN 

United Kingdom 

TYPE ESTABLI SHMENT INSPECTED 

Licensed Bul k (FFMU) Blood Grouping 

Reagent Man ufacturer 

OBSERVATION 2 

Records are not maintained in a manner which allows steps in the manufacture ofproduct to be traced.

Specifically,

a. The time FFMU Lot [(b) (4) l(Anti-A) was removed from the 2-8 °C Cold Room {b) (4) on July 30, 2019 

was not documented on the transfer log sheet. FFMU Lot K6)(4) ,(Anti-A) was filled on July 30, 2019 from 

10:30 am to l 1 :40 am. at ambient temperature and subsequently labeled. The time FFMU Lot [(6) (4) I (AntiA) was placed in the final 2-8 °C Cold Store ~6J{.i:Jt on July 30, 2019 was not recorded. Document 20452181 , 

dated 24Feb2020, titled: [(o)(4) I states 

product (FFMU) can be held at[(o)(4) 1. 

b. Complex calculations and [(o)(4) I testing results are not reviewed by a second individual or included in 

the batch record for alI licensed FFMUs (For Further Manufacturing Use). A review of the batch record, [(l:5)(4) I 

( an Anti Cw FFMU), revealed that the [(6)(4) I· used in the production of the FFMU 

were tested fo (o)(4) I To determine acceptability of 

these 6 4 ' for use in production, the technician must perform complex caJculations and assess [(o)(4) I. 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEl;(S) SIGNATURE 

Prabhu P Raju , Investigator - Team 

Bio _,...., l ogics =;lb•'--~ 

Nirnrny Mathews, Investigator X ou~~m:a,1 

OAT~ ISS!AeO 

2/27/2020 

FORM FDA -4U (O,~) PR£VIOUS EDITIOSoesa,im; INSPECTIONAL OBSERVATIONS PAGE 2 ol 3 PAGES 
DEPARTMENT OFHEALT H AND HUMAN SERVICES 

r-ooo AND DRUG ADMINISTRATION 

ClSTRICT AOORESS AND PHON~ NUMBER 

10903 New Hampshire Ave , Bldg71-5128 

Silver Spring, MD 20993-0002 

240-402-8906 

orabioinspectional correspondence@fda. hhs . gov 

OATE(S) OF INSPECTION 

2/20/2020- 2/ 27/2020* FEl tlUMeER 

3002638287 

NAMEAro Tlll.E OF llDVllUM. TO VIHOM REPORT ISSUED 

Mr . Adrian Birkett, Head of Oper ations FIRM NAME 

Millipor e (U . K. ) Ltd . 

STREET ACORESS 

2 Fl eming Road, Kirkton Campus 

CITY, STATE. ZIP""""', OOUN 11<r 

Livingston, West Lothian, EH54 7BN 

United Kingdom 

TYPE EST ABllSHMENT l""°'EClEo 

Licensed Bulk (FFMU) Bl ood Grouping 

Reagent Manufacturer 

However, these calculations and assessments are not reviewed by a second individual. Furthermore, the 

calculation or assessment of the b)(4 is not documented in the batch record of the FFMU to be reviewed by 

quality prior to batch release. 

*DATES OF INSPECTION

2/20/2020(Thu ), 2/2 l/2020(Fri), 2/24/2020(Mon ), 2/25/2020(Tue), 2/26/2020(Wed), 2/27 /2020(Thu) 

SEE REVERSE 

OF THIS PAGE 

EMPI.OYEE(S) SIG.'IATURE 

Prabhu P Raju, Investigator - Team 

Biologics 

Nimmy Mathews , Investigator 

OATE ISSUEO 

2/27/2020 

f'OR~f FDA OJ (09-,,S) PREVIOUS EDmON 08S01Zlll INSP.ECTIONAL OBSERVATIONS PAGE 3 0( 3 PAGES 
The observations of objectionable conditions and practices listed on the front of this form 

are reported: 

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 

2. To assist firms inspected in complying with the Acts and regulations enforced by the 

Food and Drug Administration. 

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: 

"Upon completion of any such inspection of a factory, warehouse, consulting 

laboratory, or other establishment, and prior to leaving the premises, the officer or 

employee making the inspection shall give to the owner, operator, or agent in charge a 

report in writing setting forth any conditions or practices observed by him which, in his 

judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) 

consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has 

been prepared, packed, or held under insanitary conditions whereby it may have become 

contaminated with filth, or whereby it may have been rendered injurious to health. A copy 

of such report shall be sent promptly to the Secretary."