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FDA Inspection
•C & A Scientific Company, Inc.•October 16, 2024

C & A Scientific Company, Inc. – FDA Inspection, Oct 16, 2024

Record Details

This FDA Inspection record concerns C & A Scientific Company, Inc., with an inspection on October 16, 2024, issued by the Baltimore District Office, covering medical devices & rad health.

Company
C & A Scientific Company, Inc.
Inspection Date
October 16, 2024
Product Type
Medical Devices & Rad Health
Office
Baltimore District Office
Person
  • Tiki Dixon
View Company Profile

ID · f4a5c3d2-af0b-4540-8026-d52aa0ce00ee

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1251806
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

8
  1. 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
  4. 21 CFR 820.22Quality audits - Lack of or inadequate procedures
  5. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  6. 21 CFR 820.25(b)Training - Lack of or inadequate procedures
  7. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  8. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

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