FDA Inspection
Lymol Medical CorporationLymol Medical Corporation – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Lymol Medical Corporation, with an inspection on June 24, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lymol Medical Corporation
- Inspection Date
- June 24, 2016
- Product Type
- Drugs
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ID · ec8f4d44-25fd-4a65-9a46-595698c6d49d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976447
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 17 citations.
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Other FDA inspections of Lymol Medical Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2020 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 15, 2011 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| September 14, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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