To: Clinical Resolution Laboratory, Inc
1400 W. Lambert Rd, Suite C
Brea, CA 92821
From: Laon Co LTD
2172-5 Jung Wang Dong 2ba 805
Siheung-Si Gyounggi-Do. KOREA
Aug 13th, 2020
Dear President Justin Lee (Clinical Resolution Laboratory, Inc (USA),
Regarding the documents requested in connection with your 8Apr19 mail ISO 13485 and ISO 14971
audit
Responses, materials and records are sent as follows.
1. Confirming MTS Roller Design Changes:
Since the last year's audit, there have been no changes in design matters, and the changes requested
there was no.
2. Confirming SOP Change Records:
Since the last year's audit, the working standards and raw materials MSDS are the same as the
documents sent last year.
Nothing has changed in the meantime.
The history of products produced according to the work standard is the order receipt book and product
delivery statement in the attached file.
You can check it.
(Attachment: LM-P-701-05 order receipt book, LM-P-704-02 product delivery statement)
3. Production Cleanliness and Environment Records
The hygiene management of the workplace and the hygiene management checklist of the workers are
conducted in accordance with established rules.
Please refer to the attached file.
(Attachment: LM-P-602-01 Hygiene Management Checklist, 02 Worker Hygiene Management Checklist)
Laon Co.,Ltd
Sihwa Industrial Complex Jeongwang-Dong
Siheung-si Gyeonggi-do(Seoul 429-934 Korea)
Tel : (82)-31-498-6730, (82)-31-498-6731
Fax : (82)-31-434-1067